Catalog Number UNK COMPREHENSIVE HUMERAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Loss of Range of Motion (2032); Subluxation (4525); Muscle/Tendon Damage (4532)
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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: 0001825034-2022-02041.Concomitant medical products: item# unknown comprehensive glenoid; lot# unknown.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 1 patient was identified as having subscapularis failure with anterior subluxation and pseudoparalysis but declined surgical intervention.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: component code-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 for subluxation.The root cause of the subscapularis failure and pseudoparalysis was determined to be unrelated to the implanted zimmer biomet device.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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