MAUDE Adverse Event Report: ARTHREX, INC. CR TIBIAL BEARING, SIZE 5, 11MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	CR TIBIAL BEARING, SIZE 5, 11MM, VIT E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a revision left total knee procedure took place on (b)(6) 2018 due to instability.Original surgery was performed by a surgeon on (b)(6) 2017.The original tibia component implanted on (b)(6) 2017 was explanted during the revision procedure that took place on (b)(6) 2018.The revision procedure was performed by a different surgeon at a different facility.The explanted device appeared intact, and integrity unaffected.Tibia poly exchange, cr+ 5//16, patient presented with appropriate spacing and stability.Surgeon attempted a 5//18 tibia poly, but it did not fit.Distal tibia tendon insertion was repaired using a 4.75 double loaded swivelock and then surgeon proceeded with closure.Additional information has been requested.Additional information received (b)(4) 2018: the rep confirmed that the correct date of the original procedure was (b)(6) 2017.The rep stated that ar-523-r511 (lot: 5791630) was explanted during the revision surgery, and ar-503-a516 (lot 113601428) was implanted during the revision surgery.The surgeon stated that the revision surgery was not due to an arthrex device.The revision took place due to ligament issues, not arthrex implants.

• Brand Name: CR TIBIAL BEARING, SIZE 5, 11MM, 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: 8226746
• Report Number: 1220246-2019-00835
• Device Sequence Number: 1592788
• Product Code: MBH
• UDI-Device Identifier: 00888867244443
• UDI-Public: 00888867244443
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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: 10/31/2021
• Device Model Number: CR TIBIAL BEARING, SIZE 5, 11MM, VIT E
• Device Catalogue Number: AR-523-R511
• Device Lot Number: 5791630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/08/2019
• 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