MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2024-00858 multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00858 d10: concomitants: (b)(6) 02-012-60-1425 - tru stem ext 14mm x 25mm (b)(6) 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t (b)(6) 200-07-32 - advanced patella 32mm 3 peg implant (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 521-78-23 - threaded pin size 2.3 collared 2pk (b)(6) 521-78-32 - threaded pin size 3.0 collarless 2pk.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening 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.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty, and then experienced revision surgical procedure approximately 60 months after initial implant.Premature poly wear and aseptic femoral loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20780014
• Report Number: 1038671-2024-04505
• Device Sequence Number: 5004885
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 02-020-11-0340
• 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: 11/09/2023
• Initial Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 06/04/2018
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female