Catalog Number UNK COMPREHENSIVE HUMERAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02030.Concomitant medical products: item# unknown comprehensive glenoid; lot# unknown.Initial reporter name and address: full establishment name - (b)(6).Literature - article title - failure rates and outcomes after anatomic total shoulder arthroplasty are equivalent irrespective of subscapularis repair technique customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 that a journal article was retrieved from seminars in arthroplasty: jses (2021), involving a retrospective study conducted in the united states.The purpose of the study was to compare the clinical subscapularis failure rates between transosseous repair (tor) and direct primary tendon repair (ptr) in patients who had anatomic total shoulder arthroplasty (tsa).The study reported 5 patients underwent reoperation due to arthrofibrosis/scarring.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: proposed component code - mechanical (g04) - head.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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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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