Model Number 1125224 |
Device Problems
Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Laxity (4526)
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Event Date 07/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Per (b)(4) initial report: additional information, including the primary surgery usage ticket, the lot code of the explanted device, x-rays, operative notes, patient age, activity level, medical history and weight, if the patient experiences any slips/trauma post primary surgery, if the patient followed the correct posrt op protocol and an update on the patient post revision and why the thickness between the device implanted in the first surgery and the one implanted during the revision surgery is so important, has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Unity revision after approx.8 months due to the cs insert disengaged from the tray.
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Event Description
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Unity revision after approx.8 months due to the cs insert disengaged from the tray.
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Manufacturer Narrative
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Per -4889 final report.Additional information, including the primary surgery usage ticket, the lot code of the explanted device, x-rays, operative notes, patient age, activity level, medical history and weight, if the patient experiences any slips/trauma post priamry surgery, if the patient followed the correct posrt op protocol and an update on the patient post revision and why the thickness between the device implanted in the first surgery and the one implanted during the revision surgery is so important, has been requested in order to progress with the investigation of this event.Part of this information was provided: the patient is 52 year-old male active worker, there was no injury to repprt after his primary surgery, he followed post op protocol and is doing well following the revision.The thickness difference between in the inserts implanted in the first surgery and the revision one is probably because the patient's knee stretched out somewhat and the surgeon did some soft tissue releasing during the poly swap.The 16mm insert was the snuggest and most secure fit for him.Pre-revision x-rays were also provided.Review of the x-ray and pictured confirmed the cs insert disengaged posteriorly.The femoral component was then bearing on the edge on the poly and distorted it due to weight bearing.The device details of the devices implanted during the primary surgery were provided and the relevant device manufacturing records were located and reviewed.The finished devices conformed to material and dimensional specification at the time of manufacture.Based on the above, the root cause of the issue that led to this revision is considered unknown.This case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Search Alerts/Recalls
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