Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 05/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 30.32.06 ¿ protasul head ¿ unknown lot.Unknown cup ¿ unknown part and lot.Unknown stem ¿ unknown part and lot.Report source australia.Product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that patient underwent a hip revision approximately 6 months post implantation due to dislocation and stiff spine.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4 (expiration date/ udi); d9; g3; h2; h3; h4; h6 corrected: d4 (lot number) no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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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Event Description
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No additional event information to report at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Corrected: e1, g2 g2: report source new zealand.
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Search Alerts/Recalls
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