MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-2015
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Fibrosis (3167); Joint Laxity (4526); Implant Pain (4561)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-06-0220 - tru cc femoral size 2 left, (b)(6) - 02-010-06-0521 - tru post.Aug.Size 2, 5mm, (b)(6) - 02-010-06-0521 - tru post.Aug.Size 2, 5mm, (b)(6) - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t, (b)(6) - 02-012-50-2011 - tru tib aug 1/2 size 2, 5mm, (b)(6) - 02-012-50-2011 - tru tib aug 1/2 size 2, 5mm, (b)(6) - 02-012-60-1080 - tru stem ext 10mm x 80mm, (b)(6) - 02-012-60-1280 - tru stem ext 12mm x 80mm, (b)(6) - 200-02-35 - three peg patella 35mm, (b)(6) - 208-06-02 - cc distal fem augment sz 2, 10mm, (b)(6) - 208-06-02 - cc distal fem augment sz 2, 10mm, (b)(6) - 201-78-25 - small headed sharp pin, 1 1/8" 4 pack, (b)(6) - 203-96-21 - (11-2714) saw blade 90x13/21x 1.9mm, (b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk, (b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00360, 1038671-2025-01646.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
It was reported via legal documentation that approximately 97 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, femoral component loosening, increasing pain, marked stiffness and decreased range of motion.Initial surgery and revision surgery operative notes were provided.Findings indicated gross loosening femoral component; marked arthrofibrosis without evidence of infection; osteopenia with significant proximal femoral bone thinning; subsidence of the patellar component with aggressive bone overgrowth and patella baja.The surgeon performed a revision of the femoral component and tibial polyethylene.The surgeon noted that the femoral condyle medially cracked during impaction of the revision femoral components, which was then stabilized with a pin.The patient was transferred to the recovery room without difficulty.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, instability, loss of range of motion, subsidence/migration, and prosthesis wear.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 radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRU CC TIB INSERT SIZE 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21679761
• Report Number: 1038671-2025-01647
• Device Sequence Number: 7600386
• Product Code: JWH
• UDI-Device Identifier: 10885862613325
• UDI-Public: 10885862613325
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 09/18/2023
• Device Catalogue Number: 02-012-65-2015
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 49 KG