MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-72-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 200-02-35, 2308176 - three peg patella 35mm; 204-04-33, 2410946 - trapezoid tibial tray sz 3f/3t; 230-02-03, 1372763 - optetrak asy,cr cemented femoral, sz 3.
Event or Problem Description
It was reported by legal that this male patient needs a knee revision due to the recall.No further information provided.
Additional Manufacturer Narrative
D10.Concomitants: (b)(6); 200-02-35 - three peg patella 35mm; (b)(6); 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t; (b)(6); 230-03-02 - optetrak asy,cr cemented femoral, sz 2.
Event or Problem Description
As reported via legal filing a patient had an initial right knee arthroplasty on (b)(6) 2012 and then on a revision surgery on (b)(6) 2017, approximately 4 years, 8 months, after the initial implant.The stated reason for the revision is secondary to complete polyethylene liner wear resulting in metallosis and dislocation.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been due to prosthesis wear, resulting in metallosis and dislocation.The extent and root cause of the prosthesis wear and sequence of events could not be determined as the device was not returned for evaluation, and images, radiographs, and operative notes were not provided.

• Brand Name: CR TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16593196
• Report Number: 1038671-2023-00490
• Device Sequence Number: 20165090
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2015
• Device Catalogue Number: 200-72-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 09/07/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/01/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male