Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 11/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: unknown screw unknown, unknown screw unknown , unknown screw unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 01097.0001822565 - 2024 - 01099.0001822565 - 2024 - 01100.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient was having right hip pain for many years.Patient underwent a complex right revision total hip arthroplasty due to aseptic loosening and pelvic acetabular periprosthetic fracture.Patient was aware of the consequences due to the complex procedure.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Updated.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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 event information to report at this time.
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Search Alerts/Recalls
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