Catalog Number UNK COMPREHENSIVE STEM |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign source: event occurred in turkey.Literature - clinical outcomes of two-stage implantation in reverse shoulder arthroplasty for postinfectious end-stage glenohumeral arthritis in native shoulders: a single-center cohort study with a minimum 2-year follow-up.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported a journal article was retrieved from clinics in orthopedic surgery (2022) that reported a retrospective study from turkey.The purpose of the study was to demonstrate the clinical outcomes of two-stage implantation in reverse shoulder arthroplasty (rsa) using an antibiotic spacer in the first stage.The study reported one patient experienced humeral stem loosening post second stage shoulder arthroplasty.No reoperation was required, and no further complications were reported.Attempts have been made and no further information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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