MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL POR, LEFT, SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-04-0230
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 02-012-49-3009 - logic cr tib insert slope++, sz 3, 9mm: (b)(6); 02-010-04-0230 - logic cr femoral por, left, sz 3: (b)(6); 200-02-35 - three peg patella 35mm: (b)(6); 201-78-15 - holding pin mini sharp point 4 pk: (b)(6); 201-78-81 - 3 trocar, mod.Hex 2pk: (b)(6); 521-78-23 - threaded pin size 2.3 collared: (b)(6); 521-78-23 - threaded pin size 2.3 collared: (b)(6); 521-78-32 - threaded pin size 3.0 collarless: (b)(6); a10012 - gps implant kit v2: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately four years post initial left side tka, the female patient had a revision due to poly wear.Patient was revised into a logic ps tkr.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation as they were disposed at the hospital, no other patient information/medical history reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d1, h6.The revision reported was likely the result of improper implant position, the overall posterior slope of the insert and/or potential ligamentous/soft tissue imbalances which allowed for increased posterior contact between the femoral component and the tibial insert and led to the observed damage of the polyethylene.Additionally, a contributing factor to the observed damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not returned for evaluation and radiographs were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.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 FEMORAL POR, LEFT, SZ 3
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21538475
• Report Number: 1038671-2025-01460
• Device Sequence Number: 17917039
• Product Code: JWH
• UDI-Device Identifier: 10885862158246
• UDI-Public: 10885862158246
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 12/02/2023
• Device Catalogue Number: 02-010-04-0230
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female