MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-51-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2019.The patient was revised on (b)(6) 2023 due to poly wear, and the liner and patella were exchanged.The patient was last known to be in stable condition following the event.There was no reported breakage of a device or surgical delay/prolongation.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.D10: three peg patella 38mm 200-02-38 5809839 or three peg patella 38mm 200-02-38 5809847.Unknown which is right or left.H7: z-0021-2022.
Additional Manufacturer Narrative
H3: the reason for the revision reported cannot be determined, but may be related to the inclusion of the implanted polyethylene in the packaging recall.Based on the provided information, it does not appear to be the result of prosthesis wear.However, this cannot be confirmed as the devices are not available for evaluation.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17322269
• Report Number: 1038671-2023-01658
• Device Sequence Number: 12334876
• Product Code: JWH
• UDI-Device Identifier: 10885862230461
• UDI-Public: 10885862230461
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: 02-012-51-3513
• Device Catalogue Number: 02-012-51-3513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male