MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-49-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 years post op the initial left tka, this 62 y/o male patient was revised due to the poly delaminating.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Device is not returning, disposed of by hospital.
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): lgc tibial fit tray cem sz 3.5f / 4.5t - 02-012-45-3545, (b)(4).Three peg patella 38mm - 200-02-38, (b)(4).Logic cr femoral cem, left, sz 3.5 - 02-010-03-0235, (b)(4).
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of third body wear and rotational mismatch between the femoral and tibial components which led to wear of the tibial insert.However, this cannot be confirmed because the component was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11 no device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified, there is pitting on the surface of the revised tibial insert which appears consistent with third body wear.Third body wear occurs when a third body, such as a fragment of bone or bone cement, gets trapped between the polyethylene insert and the condyles of the femoral component.As the patient moves, the third body creates scratches, and sometimes pitting, on the surface of the implants.Additionally, the wear pattern appears uneven.The wear on the lateral sides appears primarily on the anterior while the wear on the medial side appears primarily on the posterior.This is consistent with the femoral component being internally rotated relative to the tibial tray.Additionally, there appears to be subsurface wear.This may have been due to the femoral component contacting the posterior edge of the insert.The red discoloration appears consistent with biological matter retained on the surface of the insert.Based on the offset between the femoral condyles and the pegs, as well as the uneven curve profile, the femoral component appears to have some internal rotation relative to the tibial tray.This is consistent with the observed wear pattern on the tibial insert.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, was likely the result of third body wear and rotational mismatch between the femoral and tibial components which led to wear of the tibial insert.This cannot be confirmed because the component was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• 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: 16112405
• Report Number: 1038671-2023-00026
• Device Sequence Number: 15170392
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 07/01/2023
• Device Model Number: 02-012-49-3509
• Device Catalogue Number: 02-012-49-3509
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 03/13/2023; 05/06/2026
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/04/2023; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male