Model Number 1363-12-000 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/01/2021 |
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 stem at the cement to implant interface.Cement manufacturer is unknown.Patient had an alval on the side of her hip leading the surgeon to believe that the hip prosthesis was having micromotion causing some metal wear.Originally implants were a cobalt chrome summit cemented stem with a cobalt chrome spacer and monopolar hemi arthroplasty head.She was revised to a total hip with a pinnacle cup, altrx liner, screw, corail revision, and delta ceramic head.Lack of metalosys in joint but raised ion levels pre op.Doi: (b)(6) 2018, dor: (b)(6) 2021, affected side: unknown 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, 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 the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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