MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: (5151713) 201-78-89 - 3"" drill bit, mod.Hex 2 pack; (5151718) 201-78-89 - 3"" drill bit, mod.Hex 2 pack; (5171755) 02-022-45-4040 - truliant tib fit tray cem sz 4f/4t; (5198437) 02-020-11-0340 - truliant ps cem fem ps cem right sz 4; (5200359) 200-07-35 - advanced patella 35mm 3 peg implant; (5200870) 201-78-82 - collar fixation pin 2pk 40 mm, quick release.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 stated they underwent a knee replacement and have had trouble with the knee for 6 years.Database search found they underwent a revision procedure.Initial right knee implanted in (b)(6) 2018, revision procedure in (b)(6) 2019.No further information known.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 corrected information.The following sections were corrected: b5 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 stated they underwent a knee replacement and have had trouble with the knee for 6 years.Database search found they underwent a revision procedure.Revision procedure performed approximately 13 months after initial right knee procedure.No further information known.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 11MM
• 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
• MDR Report Key: 21305464
• Report Number: 1038671-2025-00638
• Device Sequence Number: 8848124
• Product Code: JWH
• UDI-Device Identifier: 10885862304452
• UDI-Public: 10885862304452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

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: 11/28/2025
• Device Catalogue Number: 02-022-35-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 01/16/2025; 03/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/04/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male