Catalog Number UNK SHOULDER GLENOSPHERE DELTA |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374); Joint Laxity (4526)
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Event Date 01/09/2023 |
Event Type
Injury
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Event Description
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It was reported that the surgeon stated that the patient had likely fell, or caught his arm some way that he doesn¿t remember and dislocated his shoulder.Surgeon relocated but elected to convert to the retentive insert for extra stability.Doi: (b)(6) 2022.Dor: (b)(6) 2023.Affected side: left shoulder.
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Manufacturer Narrative
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Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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