Model Number N/A |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: unknown head; catalog no#: unknown; lot#: unknown.The manufacturer did not receive x-rays for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations.As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required.The durom cup reported in this case is not marketed in the usa.A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.(b)(4).
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Event Description
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Patient was implanted on the unknown side and underwent revision surgery due to osteolysis.
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Manufacturer Narrative
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Additional information which was received on dec 14, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on the unknown side and underwent revision surgery due to osteolysis.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Complaint investigation.- dhr review: the dhr check could not be performed as the lot number was not available.- review of event description: patient is planned for revision due to osteolysis.- 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.Conclusion.No further investigation required as this issue is known and addressed in cp00000620 (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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Event Description
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No change to previously reported event.
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Search Alerts/Recalls
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