MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Laxity (4526); Joint effusion (4849)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately three years post initial right side tka, the 62 y/o male patient complained of pain.Patient had loose femur.Patient was not revised to exactech devices due to recall surgeon used competitors implants for revision.There was no breakage of a device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photo received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to recall hospital will not release.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the device was not returned for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Event or Problem Description
It was reported via legal documentation that approximately 34 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, femoral loosening, pain and recurrent effusions.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted aseptic loosening of the implant.Intraoperatively the surgeon observed some scar tissue around the patella button, but was well fixed and in good condition, and the surgeon elected to retain it.The surgeon observed, on inspection, some pitting of polyethylene insert.It was noted the femoral component was easily dis-impacted and came off cleanly from the cement mantle consistent with loosening.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: c, d, e the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the device was not returned for evaluation.The tibial insert appears unremarkable with respect to wear.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15754632
• Report Number: 1038671-2022-01424
• Device Sequence Number: 17722424
• Product Code: JWH
• UDI-Device Identifier: 10885862314574
• UDI-Public: 10885862314574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2026
• Device Model Number: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
• Device Catalogue Number: 02-020-11-0345
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 03/21/2023; 09/28/2023; 04/09/2025
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 04/12/2023; 03/06/2025; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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
• 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: ADVANCED PATELLA 35MM 3 PEG IMPLANT; TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5; TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T; TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male