Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).An additional report was submitted for this event: medwatch# 0001822565-2018-00129 concomitant medical products: trabecular metal reverse humeral stem pn: ni ln: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 in a total shoulder arthroplasty, the poly liner separated from the stem.The poly was removed and replaced.No patient impact was reported.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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