Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.00185.145; lot#: unknown.Metasul ldh, head, 46, code l, taper 18/20; catalog#: 01.00181.460; lot#: unknown.Therapy date: unknown.The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.The common clinical presentation and the date of the original implantation suggest that this case might be related to the issues for which zimmer implemented a notification in july 2008 as referenced.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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This follow-up report is being submitted to relay corrected and additional information.Dhr review: the device history records were reviewed and found to be conforming.Review of event description: patient was implanted on left side and experienced pain after the implantation.Other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event.No further due diligence required as all required information to support the conclusion is available/was already requested.Complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s instruction leaflet for endoprothesis.Conclusion: no further investigation required as this issue is known and addressed in (b)(4) (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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