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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 07/27/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient was revised approximately thirteen years post-implantation due to metallosis.During the revision, the competitor stem was found stable and without complications.When the acetabular shell was removed, metallosis tissue was debrided, and osteolytic defects were filled with grafting.The acetabular components were replaced with competitor products without complications.No further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02806 0001825034 - 2023 - 02807 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its 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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed and identified the following: trunnion clean and intact, stem stable.Metallosis tissue removed from behind the acetabular component.Severe osteolysis and defects within the acetabulum noted, hydroset applied.All zb components removed, replaced with competitor products.A definitive root cause cannot be determined.It is unknown if the off-label usage with a competitor stem caused or contributed to the event.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 further information is available at the time of this report.
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Search Alerts/Recalls
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