(b)(4).Medical products: vngd ant stblzd brg 12x63; p/n: 189022, l/n: 750670, vanguard cr ilok fem-lt 60; p/n: 183024, l/n: j6497587, biomet cc i-beam tray 63mm; p/n: 141221, l/n: j6383477, series a pat std 31 3 peg; p/n: 184764, l/n: 508290.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034 - 2019 - 04665.Remains implanted.
|
Complaint sample was evaluated and the reported event was not confirmed.Medical records were provided and reviewed by a health care professional for a left tka.Review of the available records identified limited range of motion in extension, moderate stiffness, and pain after surgery.No complications noted during surgery.Patient went under anesthesia for manipulation.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
|