MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-3510
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 30 months after a right total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain, swelling, and instability.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices: serial number item number and full description (b)(6) 208-05-03 - cc distal fem augment sz 3, 5mm (b)(6) 02-012-50-3511 - tru tib aug 1/2 sz 3.5, 5mm (b)(6) 02-012-50-3511 - tru tib aug 1/2 sz 3.5, 5mm (b)(6) 208-06-03 - cc distal fem augment sz 3, 10mm (b)(6) 02-012-61-6000 - tru offset stem ext coupler, 6mm (b)(6) 02-012-64-1680 - tru fluted stm ext 16mm x 80mm blast (b)(6) 02-012-64-1680 - tru fluted stm ext 16mm x 80mm blast (b)(6) 02-010-06-0532 - tru post.Aug.Size 3, 10mm (b)(6) 02-010-06-0531 - tru post.Aug.Size 3, 5mm (b)(6) 02-010-06-0330 - tru cc femoral size 3 right (b)(6) 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t (b)(6) 02-012-61-4000 - tru offset stem ext coupler, 4mm (b)(6) 204-70-00 - tibial stem ext.Screw the device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3.5, 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 INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19234390
• Report Number: 1038671-2024-01029
• Device Sequence Number: 5920116
• Product Code: JWH
• UDI-Device Identifier: 10885862305176
• UDI-Public: 10885862305176
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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 Catalogue Number: 02-022-44-3510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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: Required Intervention
• Patient Sex: Unknown