MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5
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); Synovitis (2094); Osteolysis (2377)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.5 years post initial right tsa, the 56 y/o female patient complained of pain.Patient had a revision due to loose femur and recalled poly.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Image and x-ray received.The devices are not available for evaluation due to hospital will not release recall implants.
Additional Manufacturer Narrative
Section d10: concomitant products: truliant tib fit tray cem sz 3.5f / 3.5t (cat# 02-022-45-3535 / serial# (b)(6)) advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(6)) truliant tib imp ps insert sz 3.5 9mm (cat# 02-022-35-3509 / serial# (b)(6) - recall# z-0023-2022) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, medical device problem coode, component code, type of investigation, investigation findings, investigation conclusions.The revision reported may have been the result of prosthesis wear, an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening, and/or due to inclusion of the polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19355604
• Report Number: 1038671-2024-01354
• Device Sequence Number: 18024524
• Product Code: JWH
• UDI-Device Identifier: 10885862314550
• UDI-Public: 10885862314550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K17024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5
• Device Catalogue Number: 02-020-11-0335
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female