Model Number N/A |
Device Problems
Fracture (1260); Naturally Worn (2988)
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Patient Problems
Failure of Implant (1924); Pain (1994); Osteolysis (2377)
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Event Date 08/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: canada.The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 00584201502.Femoral component high flex precoat rt medial/left lateral lot# 60169212.Additional associated products: 00584200402 tibial component precoat right medial/left lateral size 4 lot# unk.
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Event Description
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It was reported that the patient was revised for pain, wear, implant fracture, osteolysis approximately 17 years 8 months post implantation.Surgeon discovered that the femoral component of the knee was fractured during revision.No additional information was provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. visual examination of the returned product found that the articular surface was found to be excessively worn.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The complaint was confirmed by the device being returned.The osteolysis and pain could not be confirmed by the information provided.A definitive 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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Search Alerts/Recalls
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