MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (6629367) 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(6784578) 200-02-35 - three peg patella 35mm.(6849012) 02-020-11-0240 - truliant ps cem fem ps cem left sz 4.(6938574) 204-34-04 - fluted stem extension 40l x 14 mm.(7048613) 204-70-00 - tibial stem ext.Screw.(7095636) 201-78-97 - 2 pk, schanz pin, 3mm x 145mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (mdl no.3044).It was reported via legal documentation that approximately 33 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Plaintiff (b)(6) is currently suffering from the following complications, injuries and/or indications, some of all of which made revisions medically necessary; pain, discomfort, and difficulty walking as a result of the defective nature of the exactech knee replacement system.Plaintiff has suffered, and continue to suffer, severe and permanent personal injuries, including polyethylene wear and device failure, disbursement or the polyethylene liner into bone and other body structures, painful knee revision surgeries to remove or revise the defective device, continued rehabilitation medical care and possibly additional surgeries.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 13MM
• 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 ct; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20475049
• Report Number: 1038671-2024-04018
• Device Sequence Number: 12642224
• Product Code: JWH
• UDI-Device Identifier: 10885862304476
• UDI-Public: 10885862304476
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: 02-022-35-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (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: Required Intervention; Hospitalization
• Patient Sex: Unknown