MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal, approximately 2 years post op the initial right tka implant, this male patient was revised due to premature polyethylene wear of the tibial insert.Following the revision surgery, the patient "experiences daily pain and discomfort in his right knee which limits his activities of daily living and impacts his quality of life." no additional information.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.
Additional Manufacturer Narrative
Section h10: (d4) catalog number: 02-012-47-4009, serial number: (b)(6).Expiration date: 03-jul-2025, unique identifier (udi) #:(b)(4).(d10) concomitant device(s): 4777508 02-010-03-0340 - logic cr femoral cem, right, sz 4 4874892 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 4972565 200-02-38 - three peg patella 38mm (g4) pma/510(k)number: k111400.(h3) the revision reported was likely the result of prosthesis wear as stated in the legal documentation.However, the root cause of the prosthesis cannot be determined as the device was not available for evaluation and images, pre-revision radiographs, and operative notes were not provided.These devices are used for treatment not diagnosis.(h4) device manufacture date: 05-jul-2017.H7 & h9 section h11: the following sections have corrected information: (d1) brand name: logic cr tib insert std, sz 4, 9mm (h6) component code: 734, bearings.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• 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: 15713549
• Report Number: 1038671-2022-01391
• Device Sequence Number: 4923565
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• 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
• Report Date (Section B): 07/26/2023

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: 07/03/2025
• Device Catalogue Number: 02-012-47-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male