MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 6550213- 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5, 6378843- 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t, ab6522- 1200-a - cemex rx 40g low viscosity, ab6715- 1200-i - cemex isoplastic 40g, ab2342- 1220-i - cemex isoplastic 20g, 4996798- 200-02-26 - three peg patella 26mm, 4000621092- a10012 - gps implant kit v2.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6), 2021.They underwent right knee revision surgery on (b)(6), 2023, approximately 1 year 3 months after their initial procedure.(b)(6), 2023 op report states that there was obvious evidence of oxidation of the polyethylene with yellow discoloration.There was also pitting noted in both the medial and lateral mid portion of the polyethylene.There was no evidence of any loosening of the actual components.It was also noted that the polyethylene head of the patella had some lateral edge wear and upon further inspection, it appeared that the button was placed medial and it was a small button and there was still residual patella.The surgeon noted it looked like the patella during flexion and extension, the lateral femoral condyle was riding on the edge of the patella and was tracking abnormally resulting in abnormal patella wear on the lateral edge of the patella.The patient was brought to the recovery room in stable condition.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
Mfr #1038671-2024-05094.This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523782617
• MDR Report Key: 17346970
• Report Number: 1038671-2023-01703
• Device Sequence Number: 6543851
• Product Code: JWH
• UDI-Device Identifier: 10885862304346
• UDI-Public: 10885862304346
• 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: 2023
• 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
• Report Date (Section B): 12/31/2024

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 Expiration Date: 10/12/2025
• Device Model Number: 02-022-35-3509
• Device Catalogue Number: 02-022-35-3509
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female