MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Osteolysis (2377)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) a10012 - gps implant kit v2.(b)(6) 02-012-45-5050 - bandeja tibial logic fit 5f/5t.(b)(6) 02-010-03-0350 - logic femur cr cementado nº5 der.(b)(6) 21-0901-19y-v1 - stryker lpi s7/6/5/4 h.Sierra 90*13/21*1,19.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, who had an initial knee implant, underwent a revision procedure.Polyethylene wear with joint inflammatory reaction and osteolysis at the bone-prosthesis interface was indicated.Additionally stated ¿need for surgical intervention to prevent injury or permanent disability.Significant disability.¿ no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.Pre-revision radiograph reviewed.The right knee appears unremarkable for signs of prosthesis wear or tibial/femoral loosening.The femoral component is slightly uneven as there is slightly less room between the metal components on the medial side as compared to the lateral side.However, this observation cannot confirm the presence of component loosening.No manufacturing process-related non-conformances, deviations, or exceptions are associated with these devices.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6b, g4, h6.Mdr section codes updated/corrected: b.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 5, 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22661162
• Report Number: 1038671-2025-02630
• Device Sequence Number: 7533413
• Product Code: JWH
• UDI-Device Identifier: 10885862174543
• UDI-Public: 10885862174543
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2025

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 Expiration Date: 03/09/2023
• Device Catalogue Number: 02-012-47-5009
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 11/16/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown