MAUDE Adverse Event Report: EXACTECH, INC. TRU CC FEMORAL SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-06-0240
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	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t: (b)(6), 02-012-60-1440 - tru stem ext 14mm x 40mm: (b)(6), 02-012-60-1440 - tru stem ext 14mm x 40mm: (b)(6), 02-012-65-4009 - tru cc tib insert size 4, 9mm: (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant: (b)(6), 201-78-15 - holding pin mini sharp point 4 pk: (b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk: (b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk: (b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk:(b)(6), 521-78-36 - threaded pin size 5.1 collarless 2pk: (b)(6).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 a patient underwent an initial total knee replacement on the left side.During the procedure, it was noted that an intra-operative distal femur fracture occurred while cementing on the final femoral component.It was mentioned that the anterior flange of the implant was caught on the anterior cortex, resulting in a femoral split of approximately two (2) centimeters.The fracture was fixed using two suture cerclage.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation).The following sections were corrected: d4 (udi).H6 (health effect - clinical code).The reason for the bone fracture reported cannot be conclusively determined but may be related to a patient condition.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 4 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 22777284
• Report Number: 1038671-2025-02721
• Device Sequence Number: 15858475
• Product Code: JWH
• UDI-Device Identifier: 10885862612410
• UDI-Public: 10885862612410
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 05/23/2026
• Device Catalogue Number: 02-010-06-0240
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 96 KG