MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0340
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, following the initial right total knee arthroplasty, the patient began having complaints about their right knee.Furthermore, they lacerated their right achilles tendon and completed 6 months of physical therapy.During this recovery they felt their right knee was more swollen and painful, and they felt unstable with daily activities.Despite non-operative management, their functional state decreased significantly due to worsening right knee symptoms.They underwent a clinical, laboratory and radiologic workup that was negative for infection.Approximately 6 years and 6 months post the initial right total knee replacement, the patient was revised due to aseptic loosening.The surgeon noted there was marked synovitis encountered with tissue changes suggestive of osteolysis.The polyethylene component demonstrated pitted wear and some evidence of oxidation with yellowish discoloration grossly visible.The femoral component was found to e grossly loose and was noted to be debonded from cement in several areas, including the anterior flange and the lateral distal condyle.There was evidence of damage to the bony architecture noted secondary to osteolysis.Large amounts of osteolytic tissue and membrane were removed primarily from the medial condyle, revealing a contained type iib defect on the femur.The patellar button was noted to be well fixed.The patient was transferred to post-anesthesia care unit (pacu) in good condition after tolerating the procedure well.There is no other patient demographic or medial history available.Because the patient has filed a short form it appears they are alleging significant pain and discomfort, gait impairment; poor balance; difficulty walking; component part loosening; and other injuries presently undiagnosed, which will require ongoing medical care.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 4
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 352 377-1140
• MDR Report Key: 25855124
• Report Number: 1038671-2026-00906
• Device Sequence Number: 5266171
• Product Code: JWH
• UDI-Device Identifier: 10885862001252
• UDI-Public: 10885862001252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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 Expiration Date: 01/28/2019
• Device Catalogue Number: 02-010-01-0340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/17/2026
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male