MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 4, 10MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	PS TIBIAL BEARING, SIZE 4, 10MM, VIT E
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It has been reported that a patient who had a tka procedure (date pending) presented in the surgeon's clinic on (b)(6) 2020 with complaints of her knee feeling unstable.Follow up evaluation and x-rays were completed and reporter states it was evident that the tibial bearing implant ar-523-b410 (lot 115571546) had disassociated anteriorly.Patient did report having a fall incident reported approximately (b)(6) 2020.At that time knee joint was evaluated and assessed as stable.Revision procedure took place (b)(6) 2020.Full details on all explanted parts is pending.Additional information obtained 12/15/20: the original tka procedure was (b)(6) 2020.The only original implant that was explanted is the tibial bearing.Ar-523-b410.The bearing was replaced and all other tka components were left in the patient.
Additional Manufacturer Narrative
The device was found to have damaged and broken posterior locking tabs, damaged anterior locks, and a heavily worn inferior posterior surface.Heavy wear was also observed on the anterior side of the peg.The cause of the disengagement of the bearing from the tibial tray is undetermined and is likely due to damage to the posterior locking tabs, either during insertion or a subsequent event.Possible causes of the tabs damage include post-op trauma, misalignment with the tibial tray locking mechanism during insertion and subsequent impaction.The heavy inferior wear and peg wear likely occurred as a result of the bearing disengagement.

• Brand Name: PS TIBIAL BEARING, SIZE 4, 10MM, VIT E
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11075937
• Report Number: 1220246-2020-02431
• Device Sequence Number: 3206498
• Product Code: MBH
• UDI-Device Identifier: 00888867232464
• UDI-Public: 00888867232464
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K153586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PS TIBIAL BEARING, SIZE 4, 10MM, VIT E
• Device Catalogue Number: AR-523-B410
• Device Lot Number: 115571546
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other