MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP CR INS STD SZ 3, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a 70 yo female patient, initial right knee implanted with exactech truliant total knee system on (b)(6) 2021, was seen postoperatively in (b)(6) 2021 with complaints of ongoing pain in her knee, especially during and following physical therapy.At that time, x-rays showed questionable ingrowth in the femoral component.The patient¿s orthopedist directed her to stop the physical therapy to see if the bone might heal and return for new x-rays in a few weeks.In (b)(6) 2022 during another appointment with her surgeon.X-rays showed a failure of ingrowth of the femoral component and the doctor informed her she would need to have revision surgery in connection with both the femoral and tibial components.Revision surgery was performed on (b)(6) 2022, approximately 10 months post the initial implant procedure.The patient now walks with a cane and has been able to resume most of her activities, despite a continuing limp.She no longer needs to attend physical therapy and has been discharged by the therapist.
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.Concomitant medical products: 02-022-47-3009 - truliant tib imp cr ins std sz 3, 9mm, (b)(4), 02-022-55-3030 - truliant por tib tray size 3f/3t, (b)(4), 200-02-32 - three peg patella 32mm, (b)(4), 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 is most likely related to patient underlying conditions.
Additional Manufacturer Narrative
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.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
• 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: 15728316
• Report Number: 1038671-2022-01400
• Device Sequence Number: 19551448
• Product Code: JWH
• UDI-Device Identifier: 10885862315113
• UDI-Public: 10885862315113
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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?: No
• Operator of Device: Health Professional
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 08/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female