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Model Number N/A |
Device Problems
Biocompatibility (2886); Naturally Worn (2988)
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Patient Problems
Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
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Event Date 11/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: foreign: germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2024 -00003, 0009613350 -2024 -00005, 0009613350 -2024 -00006.
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Event Description
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It was reported a patient had an initial right total hip arthroplasty.Subsequently, identified elevated cobalt levels and began to experience pain, limiting walking and approximately 16 years after implantation, the patient had a revision with the findings of trunnionosis, osteolysis around the greater trochanter and acetabulum, trochanteric bursitis, seroma with synovitis, and tissue damage of the trochanter major.Autologous spongiosa was used to repair the acetabulum and the stem remained implanted while the cup, head, and taper were all revised with competitor products.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Products were not returned, but pictures of the explanted device during the revision surgery were provided.However, due to the low quality of the pictures and the presence of blood and tissue on the explants, an assessment of the products cannot be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information at this time.
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Search Alerts/Recalls
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