MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM LEFT SZ 4
Medical Device Problem Codes	Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post initial left side tka, the 63 y/o female patient complained of a clicking sound in her knee, the femur showed radiolucent lines on films.Surgeon revised the loose femur to a size 4 ps femur.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.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation due to hospital policy will not allow for the return of the explant.No additional patient information provided.
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp crc insert sz 4, 9mm.Cat# 02-022-51-4009, serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT CR CEM FEM CR CEM LEFT SZ 4
• 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: 15797022
• Report Number: 1038671-2022-01472
• Device Sequence Number: 4674261
• Product Code: JWH
• UDI-Device Identifier: 10885862320643
• UDI-Public: 10885862320643
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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 CR CEM FEM CR CEM LEFT SZ 4
• Device Catalogue Number: 02-020-13-0240
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 03/27/2023; 04/15/2026
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 04/17/2023; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED PATELLA 35MM 3 PEG IMPLANT.; FAN SAWBLADE EZ2213F.M63 90X22 1.27MM STRKR 5/6/7.; TRULIANT TIB FIT TRAY CEM SZ 4F / 4T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 56 KG