STANMORE KNEE IMPLANTS BANNED IN U.S. (Orthopedics This Week)
Read the Warning Letter, click here.
Extendable femoral and total knee replacement devices made by UK’s Stanmore Implants Worldwide Ltd have been refused entry into the U.S. by the FDA.
“Entry Refused”
The FDA is throwing the quality system rulebook at Stanmore and notified the company back in November 2014 in a Warning Letter that entry into the U.S. of their devices will be refused, under its authority for “detention without physical examination.” The agency also notified other U.S. federal agencies about the warning so they can take the information into account when considering the award of contracts. In addition, the agency will not consider premarket applications from the company until the quality system deviations are corrected.
Quality System Violations
During an inspection at the company in July 2014, an FDA investigator found a long list of quality system violations. Specifically, “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”
The company responded to the investigator’s observations on August 21, 2014, and again on September 26 and October 15, 2014. The last two responses were not accepted because they were not received within 15 business days of issuance of the FDA 483 report.
The violations identified by the investigator included:
- No established procedures for implementing corrective and preventive action.
- No established procedures for receiving, reviewing, and evaluation complaints by a formally designated unit. For example, the firm’s complaint handling procedure is deficient.
- No design history file (DHF) for each type of device to demonstrate that the design was developed in accordance with the approved design plan. For example, the firm does not have a DHF for the original METS Modular Distal Femur developed from 2000 to 2002.
- No procedures to ensure that design history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record. For example, the firm’s DHRs do not include the primary identification label and labeling used for each production unit. The FDA said the firm’s response to this violation appears to be adequate.
- No procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. For example, the firm’s Quality Audit Procedure includes requirements which ensure auditors do not have responsibility for the areas they audit. However, during the 2012 and 2013 Internal Audit Programs, an individual who conducted quality audits had direct responsibility for matters being audited. The inspection also revealed that the firm’s devices are misbranded, in that Stanmore failed or refused to furnish material or information regarding the devices that is required.
- Failed to report to FDA no later than 30 calendar days after the day that the firm received information that reasonably suggests that a device would be likely to cause or contribute to a death or serious injury. For example, complaints describe malfunctions occurring with the firm’s long-term implanted device. There is no information in the firm’s complaint files justifying why the referenced malfunctions would not be likely to cause or contribute to a reportable death or serious injury, if the malfunctions were to recur. These complaints should have been reported as Medical Device Report (MDR) to the FDA within 30 calendar days.
- No written MDR procedures.
Read Warning Letter and Audit Yourself
The agency’s Warning Letter is detailed and full of examples of more detailed violations. It’s worth reading as a checklist to audit your own company’s quality systems. To read the entire Warning Letter, click here.