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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
Nerve Damage (1979); Fracture, Arm (2351)
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Event Date 02/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unique identifier (udi) #: n/a concomitant medical products: comprehensive reverse shoulder humeral tray with locking ring 44 mm standard [catalog # 115340; lot 659950]; glenoid baseplate [catalog # 115330; lot 863590]; arcomxl standard humeral bearing 44 ¿ 36 mm [catalog # xl-115363; lot 745250]; versa-dial glenosphere standard 36 mm [catalog # 115310; lot 457000]; humeral stem standard 10 mm [catalog # 113650; lot 623850]; fixed non-locking screw 4.75 3.5 hex 15 mm [catalog # 180507; lot 852390]; fixed locking screw 4.75 mm 3.5 hex 20 mm [catalog # 180501; lot 851510]; fixed locking screw 4.75 mm x 15 mm [catalog # 180500; lot 468560]; fixed locking screw 4.75 mm 3.5 hex 15 mm [catalog # 180500; lot 851320]; central screw 6.5 3.5 hex 25 mm [catalog # 115381; lot 320020]; versa-dial taper adaptor [catalog # 118001; lot 380360].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 3500a will be submitted.Device remains implanted.
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Event Description
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It was reported that a patient underwent initial right reverse shoulder arthroplasty procedure.Subsequently, the patient underwent humeral repair procedure with cabling due to right periprosthetic humerus fracture.The fracture was in 4 main fragments including butterfly fragments in the medial and lateral side, and a distal fragment.During the procedure the radial nerve was noticed to have been entangled between the bone fragments.The nerve was intact, however, weak.The procedure was completed successfully with no complications.No further information is available.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records.Review of op notes confirmed the patient had a revision due to periprosthetic humeral fracture.The fracture was found in four fragments: 2 butterfly fragments, with the radial nerve found to be entrapped.Surgeon noted radial nerve intact, although weak.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not be determined with information available.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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