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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Tingling (2171); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown stem # ni lot # ni, unknown humeral liner catalog # ni lot # ni, unknown tm base plate catalog # ni lot # ni.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr repots were filled for this event: 0001822565 - 2017 - 06052, 0001822565 - 2017 - 06055, 0001822565 - 2017 - 06056.
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Event Description
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It was reported that patient underwent total reverse shoulder procedure and is experiencing tingling, pain and discomfort.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 00434901213, humeral stem, 62316674.The 00434903600, poly liner, 62232563.The 00434901500, base plate 15 mm, 62323920.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06052-1, 0001822565-2017-06055-1, 0001822565-2017-06056-1.
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Manufacturer Narrative
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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.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Device was identified of being in scope of a previous correction in 2013.Device was implanted prior to the correction.However, no information was able to be obtained to determine if the reported issue is related to the correction.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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