OBERDORF SYNTHES PRODUKTIONS GMBH UNK - EPOCA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
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Device Problem
Device Slipped (1584)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown epoca implant/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date in 2013.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2019 due to perceived loosening of a synthes epoca glenoid metalback.This prosthesis was implanted in 2013.Provided images show there has been significant wear of both the liner and metalback prosthesis which had resulted in both metallosis and glenoid erosion.The patient was revised to a reverse polarity delta extend and required a bone graft to reconstruct the glenoid.This report is for an unknown epoca implant.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.E1: additional reporter's information provided for reporting.H3, h6: investigation summary picture review got done from james amis, m.D.Medical safety officer, see response below: (re-picture review - complaint (b)(4) - uk.Msg).I can confidently confirm that the images back up the complaint including the metallosis seen.Loosening without radiographs, can¿t be confirm., it is certain to have occurred and part of the mechanical problem.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available (information or/and material), the investigation will be updated as applicable.D10: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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