MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib fit tray cem sz 3f / 2t (cat# 02-022-45-3020 / serial# (b)(4)).Truliant tib imp ps insert sz 3 13mm (cat# 02-022-35-3013 / serial# (b)(4)) the evaluation noted that reported failure of the intraoperative femoral loosening was likely the result of moving the joint around too much prior to complete cement polymerization, which allowed for the size 3 femoral component to come loose from the femoral bone.However, the contribution of the cement used, cement technique, environmental conditions in the operating room, and/or the surgical technique to the reported loosening cannot be ruled out from the information provided.Size 2.5 femoral components are only intended for use with size 2.5 tibial inserts.Exactech does not have any data or testing to support the off-label use of a size 2.5 femoral component with a size 3 tibial insert.If the joint was well-balanced and stable at the time of implantation, the size mismatch may not have much impact on articulation or joint function.The surgeon should follow up with the patient to ensure the knee feels stable.The most probable root cause associated with the reported event of "loosening - femoral" is associated with an undesired movement of the device, which may be related to the device- malfunction, misdiagnosis, or mistreatment.
Event or Problem Description
As reported, a (b)(6) y/o female patient's during initial implant, an intra-operative loosening of the femoral component was experienced.The femoral and tibial component were initially the same size.However, the femoral component was loosening but the tibial component was fixed well.Therefore, the surgeon downsized from a size 3 to a 2.5 during the surgery.The surgeon felt the flexion gap should be expanded at that time and used the femoral component size (2.5 size) as a downsizing.Patient was last known to be in stable condition following the event.The devices are not available for evaluation.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11729414
• Report Number: 1038671-2021-00187
• Device Sequence Number: 16971299
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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 3
• Device Catalogue Number: 02-020-11-0230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 74 YR
• Patient Weight: 56