Model Number 130760000 |
Device Problems
Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 09/02/2022 |
Event Type
Injury
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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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Event Description
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It was reported that screws broke off and metaglene with glenosphere detached.Surgeon removed broken bits and implanted competitor custom baseplate and humeral head with replacement depuy humeral cup poly.Broken pieces were retrieved and to be sent in.There was loosening reported at the bone to implant interface.Doi: unknown.Dor: (b)(6) 2022.Affected side: 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was returned for examination.Visual examination found the device devoid of ha coating and any kind of debris, suggesting loosening of the device, confirming the reported allegation.The reported allegation for disassociation cannot be confirmed with the information provided.Depuy synthese 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.
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Search Alerts/Recalls
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