MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-35-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 6606607, 200-07-35 - advanced patella 35mm 3 peg implant, 6617803, 02-020-11-0230 - truliant ps cem fem ps cem left sz 3, 6635734, 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, correction/removal number: z-0023-2022.
Event or Problem Description
As reported by the truliant knee clinical study, the patient had an initial left tka on (b)(6)2020.The patient presented with polyethylene wear without evidence of osteolysis.A poly exchange and possible femoral revision were indicated, but the patient declined surgical intervention at this time.The case report form indicates this event is definitely related to devices and unlikely related to procedure.
Additional Manufacturer Narrative
H3: the most likely cause for the reported prosthesis wear may be secondary to patient-related conditions.However, the extent and nature of the wear cannot be confirmed as the devices remain implanted and other contributing factors to the reported sequence of events cannot be determined as no additional clinical information or radiographs were available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the reported prosthesis wear may be secondary to patient-related conditions.However, the extent and nature of the wear cannot be confirmed as the devices remain implanted and other contributing factors to the reported sequence of events cannot be determined as no additional clinical information or radiographs were available.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15921593
• Report Number: 1038671-2022-01567
• Device Sequence Number: 5398236
• Product Code: JWH
• UDI-Device Identifier: 10885862304278
• UDI-Public: 10885862304278
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-022-35-3011
• Device Catalogue Number: 02-022-35-3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 09/11/2023; 01/21/2025
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 09/25/2023; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White