MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial left side tka, the 65 y/o female patient complaint of pain.Patient had a revision due to loose femur.Patient was revised to exactech devices.There was no breakage of the device or a surgical delay/prolongation.Images received.The device is not available for evaluation due to hospital will not release recall implants.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
D8, h3: the revision reported in the case 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 devices were not available for evaluation.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16443955
• Report Number: 1038671-2023-00240
• Device Sequence Number: 5860101
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 LEFT SZ 5
• Device Catalogue Number: 02-020-11-0250
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED PATELLA 32MM 3 PEG IMPLANT.; HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK.; HOLDING PIN MINI SHARP POINT 4 PK.; THREADED PIN SIZE 2.3 COLLARED 2PK.; TRULIANT TIB FIT TRAY CEM SZ 5F / 4T.; TRULIANT TIB IMP PS INSERT SZ 5 11MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female