ZIMMER, INC. BASE PLATE 15 MM POST LENGTH STERILE PRODUCT DO NOT RESTERILIZE; PROSTHESIS, SHOULDER
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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 glenoid head # ni lot # ni, unknown humeral liner catalog # ni lot # ni, unknown stem 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 - 06054, 0001822565 - 2017 - 06052, 0001822565 - 2017 - 06055.
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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 00434903611, glenosphere 36 mm diameter, 62304086.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06052-1, 0001822565-2017-06055-1, 0001822565-2017-06054-1.
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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.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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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