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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Weakness (2145)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It is indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant devices ¿ comprehensive primary mini length shoulder stem catalog #: 113628 lot #: 646590, versa-dial shoulder modular head with variable offset catalog #: 113034 lot #: 360110, hybrid small 4mm glenoid base catalog #: 113952 lot #: 856280, pt hybrid regenerex porous glenoid post catalog #: pt-113950 lot #: 868290.This report is number 1 of 5 mdrs filed for the same patient (reference 0001825034-2017-03514 / 03516 / 03517 / 03518).
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Event Description
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It is reported that the patient underwent a right total shoulder arthroplasty.Subsequently, pain, impingement, and 2 mm of glenoid radiolucency were noted at six (6) week post-operative follow-up.The radiolucency reportedly resolved.Unusual pain, incision line tenderness, and weakness were noted at three (3) month post-operative follow-up.The pain reportedly persisted unchanged until the six (6) month post-operative follow-up.The patient was also prescribed additional physical therapy to treat the weakness.Glenoid radiolucency was again noted eleven (11) months post-operatively.Lastly, the patient experienced tenderness at the distal portion of the surgical incision two years following shoulder arthroplasty attributable to a keloid.The surgeon has no plans to revise or otherwise treat the patient, but the patient will continue to be monitored.No additional patient consequences have been reported.
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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.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are 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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Search Alerts/Recalls
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