Model Number 1136-42-025 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/23/2021 |
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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Revision of right total shoulder due to poly wear.Original dos was over 20 years ago.Doi: 20 years ago, dor: (b)(6) 2021, right shoulder.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received indicated that the adverse consequences were that patient needed revision to reverse total shoulder due to poly wear on the glenoid component.No delay or extended surgery time.This was not a natural progression.The lot number of glenoid was illegible due to poly wear.
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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, therefore unavailable for a physical evaluation.However a photograph was provided.Upon visual inspection of the photograph, it was noticed that the photo does not depict the product that is part of the allegation.Therefore, the complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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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