MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 11 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department a 69 y/o female patient had a right knee replacement on (b)(6) 2019.Approximately 3 years and 2 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.Revision op report ((b)(6) 2023).Postoperative diagnosis: right knee arthroplasty failure.Patient had increased pain and a small effusion.Esr and crp were negative.Ct scan ruled out lysis or evidence of loosening.During the revision a small effusion without any metalosis or purulence present.A synovectomy of the suprapatellar pouch, medial and lateral gutters and intercondylar notch and then exposed the polyethylene and was able to remove the osteotome and mallet.There was some very superficial pitting of the polyethylene.The patient was awoken and transferred to the recovery room in stable condition.No complications occurred throughout the case.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-020-13-0335 - truliant cr cem fem cr cem right sz 3.5; (b)(6) 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t; (b)(6) 200-02-32 - three peg patella 32mm.Pending investigation.
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.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.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 11 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; gainesville 32653 ; 3523771140
• MDR Report Key: 16816875
• Report Number: 1038671-2023-00841
• Device Sequence Number: 17923235
• Product Code: JWH
• UDI-Device Identifier: 10885862307194
• UDI-Public: 10885862307194
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 05/25/2025
• Device Model Number: TRULIANT TIB IMP CR INS SLOPE++ SZ 3.5 11 MM
• Device Catalogue Number: 02-022-49-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 12/16/2024
• Date Device Manufactured: 05/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• 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: 69 YR
• Patient Sex: Unknown