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Catalog Number PT-113950 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Inflammation (1932)
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Event Date 11/30/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision surgery approximately four (4) years and one (1) month post-implantation due to rotator cuff failure and loose glenoid component.Surgeon stated that at the time of the primary implantation, the patient had undiagnosed inflammatory arthropathy.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03417, 0001825034-2021-03419.Concomitant products: item# 113954; lot# 996800.Item# 118001; lot# 256620.Item# 115330; lot# 734280.Item# 405889; lot# 321360.Item# 405883; lot# 291840.Item# 405800; lot# 579190.Item# 115395; lot# 346230.Item# 180554; lot# 705840.Item# 180550; lot# 464210.Item# 180552; lot# 697300.Item# 180550; lot# 787440.Item# 118001; lot# 386740.Item# 115310; lot# 244620.Item# 110031424; lot# 64980771.Item# 110031399; lot# 65142051.Item# 110004347; lot# 770440.Item# 113042; lot# 594640.Item# 115736; lot# 866520r.Item# 20-8000-000-11; lot# 63706262.Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of the provided medical records.Radiographs identified moderate-sized periprosthetic lucency surrounding glenoid screw, consistent with loosening and/or infection.Aside from the lucency, remaining bone quality is normal.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.A definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00372.
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Event Description
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No additional information at the time of this report.
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Search Alerts/Recalls
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