Model Number 130770024 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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(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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The patient was revised to address loosening of the metaglene/ glenosphere at the implant to bone interface.It reported that the glenosphere did not appear to be tightened locked down all the way.Bone loss around the metaglene appeared to contribute to loosening of that component.The reported implant was a non-cemented.Original implant date was unknown.No surgical delay.Doi: unknown, dor: (b)(6) 2021, right shoulder.
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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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