MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-2010
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee replacement on the left side.Subsequently, the patient experienced polyethylene wear without evidence of osteolysis.Patient stated she fell.As a result, approximately 2.5 years after initial replacement, the patient was administered medication.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 02-020-14-0220 - truliant cr por fem cr por left sz 2: (b)(6); 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t: (b)(6); 200-07-32 - advanced patella 32mm 3 peg implant: (b)(6).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
The reason for the prosthesis wear and patient fall reported cannot be confirmed from the information provided.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 2, 10MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21710826
• Report Number: 1038671-2025-01680
• Device Sequence Number: 10010751
• Product Code: JWH
• UDI-Device Identifier: 10885862312525
• UDI-Public: 10885862312525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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 Catalogue Number: 02-022-51-2010
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/09/2025
• Date Device Manufactured: 02/20/2019
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White