MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-3015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2020.Approximately 2 years and 11 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.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.Revision op report on (b)(6) 2023 diagnosis: failure of total knee replacement there was significant effusion and synovitis.No purulence.There was delamination of the polyethylene but evidence of prothesis loosening.The polyethylene was removed.There was osteolysis surrounding the femoral component anterior and posterior as well as the medial tibial plateau.Patient tolerated the procedure well and was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or 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, radiographs, and relevant clinical information were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653 1197
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 18452257
• Report Number: 1038671-2024-00022
• Device Sequence Number: 7155133
• Product Code: JWH
• UDI-Device Identifier: 10885862305138
• UDI-Public: 10885862305138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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: Company Representative
• Initial Reporter Occupation: Physician
• 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: 10/23/2025
• Device Catalogue Number: 02-022-44-3015
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 12/16/2024
• Date Device Manufactured: 10/24/2017
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female