STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Model Number 625-0T-28D |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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While conversing with a surgeon regarding a patient with an alleged knee construct with squeaking, the surgeon sent the following message: "just received the implant stickers of the right hip replacement of the patient with the squeaking.She does have a ceramic on ceramic hip replacement which could be the source of the squeaking." implant stickers of the hip, implanted in 2005, are provided.
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