MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CR INS STD SZ 3, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582); Joint effusion (4849)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated as the hospital would not release the implants.Concomitant medical products: 02-020-13-0330 - truliant cr cem fem cr cem right sz 3, sn: (b)(4), 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, sn: (b)(4), 200-02-32 - three peg patella 32mm, sn: (b)(4).Recall: z-0023-2022.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a 57 yo female patient, who had their right knee initially implanted on (b)(6) 2019, underwent a revision surgery on (b)(6) 2022, approximately 2 years 11 months post the initial implant procedure for unknown reasons to exchange the poly insert.The patient was last known to be in stable condition following the event.The device is not able to be returned, as the hospital would not release the implant.
Event or Problem Description
Patient diagnosed with right total knee arthroplasty with polyethylene failure and underwent surgical revision.During the revision, the surgeon stated, "we were then able to isolate the polyethylene and then able to lever it out of the tibial tray.On inspection, there was some beginning of degradation of the posterior locking mechanism." the patient continues to complain of pain and effusion to her right knee.No additional information.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.
Additional Manufacturer Narrative
H6: corrected health effect clinical code, component code, type of investigation, investigation findings.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 3, 9MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15438285
• Report Number: 1038671-2022-01130
• Device Sequence Number: 17635576
• Product Code: JWH
• UDI-Device Identifier: 10885862306371
• UDI-Public: 10885862306371
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• 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): 11/07/2024

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 Model Number: TRULIANT TIB IMP CR INS STD SZ 3, 9MM
• Device Catalogue Number: 02-022-47-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 11/06/2024
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/10/2022; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female