MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-4013
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
It was reported that this patient's left knee was revised approximately 10 years 2 months post initial operation.The patient had a total knee arthroplasty (tka) that had progressive pain and swelling in his knee.Radiographs showed asymmetric polyethylene wear worn down to metal.Arthrotomy incision was made through existing incision and 100ml of joint fluid came pouring out of the joint.There was synovitis with (>2cm) plastic fragments floating around in the knee.Poly was removed which showed extensive wear.Synovectomy was performed; knee was irrigated a new poly was placed and the knee was closed in routine fashion.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The reason for the revision reported is most likely due to prosthesis wear over the course of 10 years of implantation, which ultimately led to fracture of the posterior medial aspect of the tibial insert.The prosthesis wear may have been caused by high contact stresses on the posterior end of the insert, potential inclusion of the insert in the packaging recall, patient-related factors, or any combination of these possibilities.D1: corrected d4: corrected g4: corrected h6: corrected medical device and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22192768
• Report Number: 1038671-2025-02275
• Device Sequence Number: 13089090
• Product Code: JWH
• UDI-Device Identifier: 10885862174536
• UDI-Public: 10885862174536
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-49-4013
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 57 KG