Model Number N/A |
Device Problems
Difficult to Remove (1528); Separation Failure (2547); Physical Resistance/Sticking (4012)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: m2a-magnum mod hd sz 48mm, pn 157448, ln 164140; m2a-magnum pf cup 54odx48id, pn us157854, ln 708300; bi-metric/x por nc 13x145, pn x180313, ln 113120.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03102.
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Event Description
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It was reported that during a revision surgery, the surgeon was unable to remove the head/taper from the stem which required stem removal.The cup position required adjustment for stability and was also removed.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed through review of medical records.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that during a revision surgery, the surgeon was unable to remove the head/taper from the stem which required stem removal.The cup position required adjustment for stability and was also removed.Additional information received in revision operative report noted that the head was cold-welded to the stem.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - head.One stem and one insert were returned with the lots not confirmed.Upon visual inspection the head and the stem are stuck together and could not be separated so the lot of the stem could not be confirmed.The lot of the head and the insert have gouging with the lot not being able to be seen.The investigation could not verify or identify any evidence of product contribution to the reported problem.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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