ZIMMER BIOMET, INC. COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR RGX AUG - SMALL; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Nerve Damage (1979)
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Event Date 01/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # unknown, catalog# 211232, comprehensive segmental revision system modular stem - 10x75mm, lot # unknown, catalog# 211222, comprehensive segmental revision system tumor body - 61mm, lot # unknown.Foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-03744, 0001825034-2018-03746, 0001825034-2018-03747.Remains implanted.
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Event Description
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It was reported that during a total humerus arthroplasty patient suffered an injury to a nerve causing incomplete axillary nerve dysfunction.The patient also suffered from a hematoma two (2) days post-operatively.The patient was placed on antibiotics to treat the hematoma.Both of these issues were resolved.No further complications during procedure were reported.
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Manufacturer Narrative
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Unique identifier (udi) #: (b)(4).Catalog# 211232, comprehensive segmental revision system modular stem - 10x75mm, lot # 215950, catalog# 211222, comprehensive segmental revision system tumor body - 61mm, lot # 543430, catalog# 211278, comprehensive segmental revision system seas humeral head 48x19, lot # 886950.Report sources: (b)(6).Complaint sample was evaluated and the reported event was confirmed.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.Root cause was unable to 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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