Model Number 130790030 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Inflammation (1932); Inadequate Osseointegration (2646)
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Event Date 03/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient previously had shoulder arthroplasty revision surgery from anatomic to reverse on (b)(6) 2018.They used a bio rsa bone graft on the glenoid side due to glenoid bone loss.This bone graft resorbed and subsequently the glenoid fixation failed and the glenoid components became loose.This resulted in dislocation.The implants have all be explanted and shoulder fusion procedure carried out.There were screws in the metaglene also, however i was unable to obtain the lot numbers as they were unreadable doi: (b)(6) 2018, dor: (b)(6) 2022, unknown shoulder.
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Event Description
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Additional information received indicated that there was no surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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