Model Number L20311 |
Device Problems
Osseointegration Problem (3003); Migration (4003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 12/08/2020 |
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 stem at the bone to implant interface.The stem was also subsided so the surgeon removed head, stem, and metal liner and replaced it with a new poly liner and a competitor revision stem.Couldn¿t locate anything from the previous surgery.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020; affected side: left hip.
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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 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 device history record (mre) review, was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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