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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526)
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Event Date 01/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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: 0001822565-2024-00698, 0001822565-2024-00699.
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Event Description
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It was reported that the patient underwent a left knee revision approximately 22 months post implantation due to pain and dissatisfaction returning to previous activity levels.Radiographic imaging demonstrated concern for femoral loosening, and this was confirmed intra-operatively.The femoral component and poly were exchanged without known complications.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-op office visit: ct results: no acute bony abnormality, no evidence of fracture, no definite evidence of osteolysis or loosening however the bone around the prosthesis shows diffuse bony demineralization; patient¿s biggest complaint is medial pain and inability to resume normal previous activities, also states some numbness to sole of her foot has returned; revision surgical notes: the femoral stem was rotationally loose, the tibia was well fixed, no signs of infection, reasonably healthy bone quality.A definitive root cause cannot be determined.Complaint is confirmed with the provided medical records.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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Search Alerts/Recalls
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