Model Number N/A |
Device Problems
Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown - unknown tibial component - unknown; unknown - unknown articular surface - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00377 and 0001822565-2023-00378.
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Event Description
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It was reported that a patient underwent an initial knee arthroplasty.Subsequently, the patient has been complaining of swelling, instability, and pain.They also note the knee is hot to the touch and the leg below the kneecap is bellying out.The patient has seen multiple physicians and has had x-rays taken.With physical testing, they doctors have noticed there is loosening.Attempts have been made and no further information has been 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.H6: suggested component code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement, cortical defect/osteolysis noted in the medial femoral condyle, potential subsidence of the tibial stem.The complaint was confirmed.A definitive root cause cannot be determined.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 that the patient underwent an initial left total knee arthroplasty due to a work-related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complained of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Attempts have been made and no further information has been 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.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 3007963827-2023-00356.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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