(b)(4).Concomitant medical products: persona partial knee cmt tib lm sz f, catalog #: 42538000601, lot #: 64804375.Report source - foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that knee arthroplasty operation was performed with partial knee.During surgery, the articular surface didn't firmly mate with tibia plate.Subsequently, another surface was used to complete the procedure.It was reported that no further information is available.
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This follow-up is being submitted to relay additional information.Updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: visual examination of the returned product identified signs of use.Flared damages were seen in the locking mechanism.Review of the device history record identified no deviations or anomalies during manufacturing.The device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The complaint is confirmed.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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