Model Number 115370 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an initial shoulder replacement surgery, the locking ring of the humeral shell could not be opened and was not freely movable in the tray.The surgeon was unable to assemble the tray with the polyethylene bearing.A second set of implants was used to complete the procedure.There was a five minute surgical delay however no patient impact or adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).G2: germany: foreign.Customer has indicated that the product is in the process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product verified the part and lot number and identified the device shows slight wear and tear on the snap ring where the gap is located.The snap ring moves freely in the slot provided in the tray without issue.This complaint is not confirmed.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to use error as the surgical technique states that the assembly tool should be used to assemble the tray.It was reported that an unknown clamp was used to assemble the tray instead of the bearing assembly tool.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 at time of this report.
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Search Alerts/Recalls
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