It was reported initial right tka was performed on unknown date.Subsequently experienced pain, limited rom, instability, stiffness and underwent a mua on an unknown date with no resolution of symptoms and a right tka revision was performed about 2 years post implantation.During the revision scar tissue was excised.Tibia, femur and articulating surface were revised/exchanged without complications.
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(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: kne-persona-femorals-unk, mdr: 0001822565-2022-03468.Kne-persona-tibial trays-unk: mdr: 0001822565-2022-03469.
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This follow-up report is being submitted to relay additional information. no product was returned or pictures provided were insufficient to perform visual or dimensional evaluations.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review of the available operation notes identified the following: pain, instability, stiffness, and mua since initial surgery, rom: 10-105, x-ray: anterior slope, of tibia component, spinal, ebl 50 ml, no infection, scar tissue removed; flexion increased to 120, patella well fixed and remained intact, no loose component, no complications.The complaint was confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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