Catalog Number 00771301000 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # 00625006525 / bone screw/ lot # 62466422.Part # 00625006525 / bone screw/ lot # 62466422.Part #00784802300 modular neck/ lot # 62335280.Part # 00801803202 / femoral head / lot # 62498217.Part # 62025020 / shell / lot # 62064875.Part # 63105032 / liner/ lot # 62449618.Part # unknown / femoral head allograft/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00277.0002648920 -2020 -00276.0001822565 -2020 -01866.0001822565 -2020 -01865.
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Event Description
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It was reported that during a diagnostic radiology 4 years post implantation that there was bending of the screws of the left superior acetabulum.Slight leg length discrepancy, with the left leg longer than the right (1cm).No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon receipt of additional information, it was determined this device did not contribute to the reported event and should be voided.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this device did not contribute to the reported event and should be voided.
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Search Alerts/Recalls
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