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

Device Problems Unstable (1667); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2018

Event Type  Injury  

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 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
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8226746
• MDR Text Key: 132383162
• Report Number: 1220246-2019-00835
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888867244443
• UDI-Public: 00888867244443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other