MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t - 2847821 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t - 3692222 200-02-35 - three peg patella 35 mm - 3596969 200-02-35 - three peg patella 35 mm - 3739349 unknown which implant is right or left.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that the discoloration on the underside of the femoral component appears consistent with exposure to bone cement.The absence of bone cement adhesion was noted on the underside of the femoral component.Properly functioning implants depend on their appropriate fixation to the bone; fixation is usually achieved by cementing the implant onto the bone.Although implants are firmly fixed at the initial knee replacement surgery, they may become loose over time.Friction caused by the joint surfaces rubbing against each other wears away the surfaces of the implant, creating tiny particles that accumulate around the joint.In a process called aseptic (non-infected) loosening, the bond of the implant to the bone is also digested (a condition called osteolysis), which can weaken or even fracture the bone.When the prosthesis becomes loose, the patient may experience pain, change in alignment, or instability.The tibial insert appears to show signs of both delamination and pitting/third body wear on the articular surfaces.Delaminating wear may be associated with sliding or translational movement between the tibial and femoral components and high contact stresses.Third body wear occurs when particles such as cement or bone become trapped between the femoral component and tibial insert, resulting in pitting and grooves in the polyethylene tibial insert.However, this cannot be confirmed as provided image does not provide a clear visual of the articulating surface due to the lighting/glare.The subsurface cracking and full-thickness fracture of the posterior edges of the insert may indicate that the knee was undergoing a significant amount of flexion resulting in localized high in-vivo pressure on the posterior edge.Uneven pressure distribution from instability and malalignment can result in increased wear of the polyethylene component.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 femoral loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) femoral loosening and osteolysis was likely the result of an insufficient bond between the femoral component and the bone.The tibial insert wear may have been due to malalignment between the implants, mechanical overload during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.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.
Event or Problem Description
As reported, the patient received a bilateral total knee arthroplasty.Approximately 8 years after the index surgery, the patient¿s right knee was revised due to reported pain, femoral loosening, and polyethylene wear.Per the operative notes, the patient has increasing pain and recurrent effusions with x-ray evidence of osteolysis behind the femoral component.The surgeon elected to revise the patient with a cc femoral component, a femoral cone, one posterior augment block, two distal femoral augment blocks, a stem extension, and a ps tibial insert.The patient was last known to be in stable condition following the revision surgery.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25153018
• Report Number: 1038671-2026-00583
• Device Sequence Number: 10733619
• Product Code: JWH
• UDI-Device Identifier: 10885862001887
• UDI-Public: 10885862001887
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 02-012-35-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 05/12/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male