Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094); Osteolysis (2377); Reaction (2414); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products: unknown tibial component catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-03853.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient will be considered for revision due to allergies.Patient alleges to be allergic to zirconium and chromium.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.
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Event Description
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From additional information received, it was reported that the patient has indicated for revision due to metal allergies, pain, swelling, stiffness and synovitis.
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Manufacturer Narrative
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D11: vngd ti fem ps 65mm lt catalog # cp113639 lot # 390450.Biomet finned pri stem 40mm catalog # 141314 lot # 530850.Vngd ps tib brg 11x63/67 catalog # 183621 lot # 649610.Series a asymmetric pat 31x8 catalog # 184792 lot # 711690.Simplex cement catalog # unknown lot # unknown.Multiple mdr: 0001825034-2020-04011.
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Event Description
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From additional information received, it was reported that the patient has indicated for revision due to metal allergies, pain, swelling, stiffness and synovitis.Also due to osteolysis, noise/clunking, loosening and migration.Further, office notes indicate that the leg is swollen at the end of the day causing it to be stiff.A baker's cyst pops out behind the knee causing sharp pain to the inside of the kneecap.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records review indicates that metal allergy to mercury, nickel, tin, chromium, vanadium and zirconium.Popping and clunk with prosthesis.Femoral component is slightly rotated into flexion 5-10 degrees.Lytic lines along cement mantle, especially along femoral component.Mechanical loosening of the knee.X-rays show no evidence of hardware complication with mild join effusion and soft tissue swelling.Bone scan shows abnormal asymmetric uptake of radiopharmaceutical around the total knee hardware in the left knee.Most prominent around the femoral component with activity around the tibial component.By end of the day left leg is swollen causing the knee to be stiff.A bakers cyst pops out behind the knee by the end of the day causing sharp pain inside of the kneecap.Synovitis of the joint of the left knee likely due to reaction to the metals.No evidence of loosening and cultures are all negative.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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