Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Joint Laxity (4526)
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Event Date 04/06/2022 |
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 completed due to instability.Patient fell, broke the liner in their existing tha.The liner, stem, and head were removed.Doctor used a revision stryker stem/ head and used our dual mobility implants for the acetabular side.There was loosening of the stem at the bone to implant interface.Doi: unknown; dor: (b)(6) 2022; affected side: right 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 investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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 records evaluation (mre) was not performed as no lot number was provided for this device.
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Search Alerts/Recalls
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