MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535); Aseptic loosening (4883)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-012-41-5050 - logic tibia traptray cem sz 5f/5t, (b)(6), 02-012-44-5011 - logic tibia implant psc insert, sz 5, 11mm, (b)(6), 200-02-38 - three peg patella 38mm.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01120.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.
Event or Problem Description
Report #2 of 2 for this event.It was reported a patient had an initial left knee arthroplasty.Subsequently, ten (10) years, three (3) months later, the patient experienced pain and osteolysis and aseptic (non-infected) loosening.Additionally, as reported via legal documentation, the patient continues to experience pain, discomfort, difficulty walking, balance issues and soft tissue damage.As a result, the patient underwent a left knee revision.A revision operative report was provided.The pre and post diagnosis was noted as polyethylene wear, osteolysis and femoral loosening.Intraoperatively, it was observed that the femoral component was loose and the tibial component was well fixed with a substantial amount of medial osteolysis.The patellar component was well fixed, and the surgeon elected to retained due to concerns of a well-fixed component that may have resulted in unnecessary patellar bone loss.Final relocation of the revision arthroplasty revealed a stable replacement.The patient was transferred to the recovery room in stable condition.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 5
• 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 32653
• Manufacturer Contact: ashely harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24740713
• Report Number: 1038671-2026-00358
• Device Sequence Number: 17252486
• Product Code: JWH
• UDI-Device Identifier: 10885862001177
• UDI-Public: 10885862001177
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 04/30/2016
• Device Catalogue Number: 02-010-01-0250
• 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: 08/16/2022
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 05/03/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male