Model Number N/A |
Device Problems
Flaked (1246); Peeled/Delaminated (1454)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/28/2019 |
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 it remains implanted in the patient.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 during a initial hip procedure, it was noted the surgeon broached to 8 stem.When he went to implant the stem, it sat very proud; he only tapped it 2 or 3 times.He pulled it out to broach it again and noticed some pps seemed to have come off on the medial crack and left coating in the femur.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the attached pictures do not show any signs of the pps coating delaminating.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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Search Alerts/Recalls
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