MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-51-2015
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Implant Pain (4561)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this female patient's knee was revised due to pain and synovitis.The surgeon performed releases and implanted a new 15 crc insert with good range of motion and stability.There was no surgical delay or issue with any devices during the revision procedure.The patient left in stable condition.The explant is not available.No additional information is available.
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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient conditions.Concomitant medical products: (b)(4), 02-010-03-0320 - logic cr femoral cem, right, sz 2.(b)(4), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(4), 200-02-35 - three peg patella 35mm.(b)(4), 201-46-10 - holding pin headless 3" (4 pk).Unassigned, 213-49-00 - lpi collar drill.Unassigned, 201-45-00 saw guide holding drill 1/8 x 5.
Additional Manufacturer Narrative
If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c.The revision reported was likely the result of tibial insert prosthesis wear.Possible causes of the observed polyethylene wear include third body wear, patient-related factors, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2, 15MM
• 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: geoff gannon ; 3523771140
• MDR Report Key: 15758396
• Report Number: 1038671-2022-01429
• Device Sequence Number: 6238586
• Product Code: JWH
• UDI-Device Identifier: 10885862230355
• UDI-Public: 10885862230355
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/25/2025

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: 03/22/2021
• Device Model Number: 02-012-51-2015
• Device Catalogue Number: 02-012-51-2015
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 03/05/2025; 09/24/2025
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 03/06/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2013
• 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
• 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 Sex: Female