Model Number 86-6875 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2022 |
Event Type
malfunction
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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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It was reported that on (b)(6) 2022, a knee revision surgery was performed at (b)(6) hospital.During the operation, rod "trial" was used to check the fit of the implants.In the patient's limb photo taken today, the "trial" rod was observed at the bottom of the leg.At this stage it is not known whether the incident affects the patient's health and / or whether further surgery is planned to remove the trial rod.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.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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