Catalog Number UNKNOWN COMPREHENSIVE GLENOID |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
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: 0001825034-2022-02050.Concomitant medical products: item# unknown comprehensive humeral head; 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 underwent subscapularis repair due to subscarpularis failure with anterior subluxation.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.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 rotator cuff injuries occur most often in people who repeatedly perform overhead motions in their jobs or sports.Degenerative tears can also occur as a result of a wearing down of the tendon that occurs over time.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.An injury or failure in any of the rotator cuff tendons can result in laxity and subluxation of the joint.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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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