Model Number 1987-27-212 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information received november 1: answers: a.What was the duration of the surgical delay? - 20 minutes.B.Was the device available for return? - yes.C.Was there any adverse consequences that affected the patient because of the reported event? - no, there were no consequences.D.Was there any alleged deficiency to the tibial tray? if yes, please provide details.- the tibial component was functional and also not damaged during the insertion process, so another insert was installed instead of the defective one.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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According to the distributor: revision total knee arthroplasty (s-rom-mbt) was performed.When installing the liner, the doctors found that the inner metal part was not fixed in the liner, so it was impossible to install it.The patient suffered because it became necessary to install a larger liner (14mm), because.The liners were in a single size, there was a delay in the operation.Product photo: attached.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence provided was reviewed and insufficient evidence to confirm, the device was damaged upon receipt.It was not possible to determine, the time the device got damaged.However, the device does look separated, but it was not possible to determine if the time of occurrence was prior or after delivery.Additionally, the device presents visible scratches close to the separated portion.The packaging portion visible on the photos does not indicate any damage to it.It only has the cellophane partially removed.The reported damaged upon receipt condition was not confirmed.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device (product code 198727212/lot j95j20) product and lot numbers, and no non-conformances were identified.
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Search Alerts/Recalls
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