MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants - product information: 4894802 200-02-35 - three peg patella 35mm; 5001784 02-012-60-1440 - tru stem ext 14mm x 40mm; 5030261 02-020-13-0250 - truliant cr cem fem cr cem left sz 5; 5144233 204-70-00 - tibial stem ext.Screw; 5146142 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left knee arthroplasty on (b)(6) 2018, and then experienced a revision surgical procedure on (b)(6) 2023, approximately 5 years, 10 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed and 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.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 5, 9MM
• 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
• MDR Report Key: 19274629
• Report Number: 1038671-2024-01138
• Device Sequence Number: 18036633
• Product Code: JWH
• UDI-Device Identifier: 10885862306579
• UDI-Public: 10885862306579
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Catalogue Number: 02-022-47-5009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 01/23/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown