MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-4013
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices 5949173 - 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm 6933772 - 02-012-50-3011 - tru tib aug 1/2 size 3, 5mm 6237501 - 02-012-50-3013 - tru tib aug 1/2 rm sz 3, 10mm 6126068 - 02-012-50-9015 - tru tibial aug screw 15mm 6287708 - 02-012-60-1680 - tru stem ext 16mm x 80mm 5789110 - 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t 6619130 - 204-70-00 - tibial stem ext.Screw h3: the mostly likely cause for the revision reported due to loosening is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the loosening of the tibial component.However, this cannot be conclusively determined.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2016 and then was revised on (b)(6) 2022.Patient required revision surgery for issues including but not limited to pain, swelling, and decreased range of motion.
Additional Manufacturer Narrative
The reason for the reported event cannot be confirmed from the information provided but may have been due to prosthesis wear and/or decreased range of motion.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.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.H6: corrected health effect, medical device and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4, 13MM
• 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
• Manufacturer Contact: matt collins ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19152770
• Report Number: 1038671-2024-00917
• Device Sequence Number: 15578694
• Product Code: JWH
• UDI-Device Identifier: 10885862307774
• UDI-Public: 10885862307774
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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 Catalogue Number: 02-022-51-4013
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 11/24/2024; 10/24/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 10/25/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown