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

Model Number	02-022-51-3510
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement (b)(6) 2020.She had the right knee revised on (b)(6) 2023, approximately 2 years 4 months after their initial replacement.Surgeon noted that upon examination of the removed poly, there was "absolutely no wear at all that i could identify from a macroscopic perspective.There was no backside wear and no wear at all, no deep delamination noted." the interface of the patella, the femur and the tibia were evaluated and found to be "pristine." there is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitant medical products: 6545522, 02-020-13-0335 - truliant cr cem fem cr cem right sz 3.5, 6559036, 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t, 6549619, 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
H10.Additional/updated information- b7., h6 all.H6.Investigation results-the device, truliant tib imp crc insert, sn (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain, instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There were no issues identified with the devices in the surgical procedure, the patient had an upsize for the tibial insert from 10mm to 15mm.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: michael crader ; 3523782617
• MDR Report Key: 16878565
• Report Number: 1038671-2023-00916
• Device Sequence Number: 12578246
• Product Code: JWH
• UDI-Device Identifier: 10885862312617
• UDI-Public: 10885862312617
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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
• Device Model Number: 02-022-51-3510
• Device Catalogue Number: 02-022-51-3510
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 61 YR
• Patient Sex: Female