Model Number N/A |
Device Problems
Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651)
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Event Date 03/23/2022 |
Event Type
Injury
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Event Description
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It was reported an initial left total knee arthroplasty, performed.Subsequently, the patient underwent a revision nine years post procedure, due to pain and loosening.No further complications were reported.
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Manufacturer Narrative
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(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.Unk tibial component: mdr: 0001825034-2022 -01135.Unk patella: mdr: 0001825034-2022-01136.Unk bearing: mdr: 0001825034-2022-01137.
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Event Description
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It was reported the patient had an initial left total knee arthroplasty.Subsequently, the patient underwent a revision approximately 9 years post procedure, due to pain and loosening.During revision, scar tissue was removed and subsidence and loss of fixation were noted related to the tibia.The patient was also found to have poor femoral bone quality.The revision system was placed in an acceptable manner and no further complications were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional associated products & mdrs.Please note it was determined during investigation of the reported event, that the part referenced in the associated product mdr: 0001825034-2022-01136, should not have been reported.The initial report for mdr: 0001825034-2022-01136 has been voided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Component code- suggested code: mechanical (g04) - femur no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Revision surgery notes state that scar tissue was removed from medial and lateral gutters.Polyethylene was quite thick, no gross damage.The femoral implant was removed quite easily and patient had significant stress shielding bone below the implant, condyles were intact but had contained defects within each.Tibial component was removed using oscillating saw, there was very little bone loss and there was no cement on the tibial keel (loss of fixation).The distal femoral bone remnant in the condyle was very poor quality- it left no doubt that significant augmentation of the femoral cone would be needed to allow good fixation.X-ray review revealed tibial component loosening with excessive posterior slope.X-ray review(2) left knee demonstrates subsidence of the medial tibial component and femoral component appears preserved.This complaint is confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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