Catalog Number 00434906506 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 07/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: unk stem, cat#: ni, lot#: ni.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdrs were associated with this event, please see associated reports: 0001822565 - 2020 - 02800.
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Event Description
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It was reported the patient underwent a total shoulder arthroplasty.Subsequently, the patient was revised two weeks later due to disassociation of the poly liner from the stem.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.D4: udi: (b)(4).Visual examination of the returned product identified: heavy gouge near anti-rotational slot.Both sides of the poly liner exhibit heavy wear.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 further event information is available at the time of this report.
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Search Alerts/Recalls
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