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

Catalog Number	02-010-06-0220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
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 and experienced an intraoperative complication.Initial and revision operative notes were provided.During impaction of the revision femoral components, the surgeon noted that the femoral condyle medially cracked and was stabilized with a pin.No other issues or complications were reported.The patient was transferred to the recovery room without difficulty.No additional information is available.
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) - 02-012-65-2015 - tru cc tib insert size 2, 15mm; (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) - 201-78-25 - small headed sharp pin, 1 1/8" 4 pack; (b)(6) - 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm; (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) - 521-78-31 - threaded pin size 2.6 collarless 2pk; (b)(6) - 521-78-31 - threaded pin size 2.6 collarless 2pk.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d1, d4, g4, h4, h6.The reason for the bone fracture was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition, a traumatic event, and/or surgical techniques.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or 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 FEMORAL SIZE 2 LEFT
• 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: 21687885
• Report Number: 1038671-2025-01652
• Device Sequence Number: 15780057
• Product Code: JWH
• UDI-Device Identifier: 10885862612397
• UDI-Public: 10885862612397
• 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
• 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): 08/28/2025

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: 09/12/2020
• Device Catalogue Number: 02-010-06-0220
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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 Age: 56 YR
• Patient Sex: Female