Model Number N/A |
Device Problems
Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 02/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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Medical product: alloclassic stem hip impl win gen; item# unknown; lot# unknown.The manufacturer did not receive devices or 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.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on right side and underwent revision surgery due to pain, difficulty in walking, elevated metal ions and metallosis.
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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 was implanted on the right side and underwent revision surgery due to pain, limitation of normal walking, elevated metal ion levels, metallosis.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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Event Description
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No change to previously reported event.
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Search Alerts/Recalls
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