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

Catalog Number	02-010-01-0240
Medical Device Problem Codes	Corroded (1131); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: ((b)(6)) 02-010-01-0240 - logic femoral ps cem left sz 4; ((b)(6)) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (s/n unknown) 200-02-38 - three peg patella 38mm.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case: (b)(4).Patient id: (b)(6) + left knee (b)(4), right knee is associated with this case.7/24/24: additional information received in in-box on 7/24/24.Attached email and revision op report.Indication for procedure: over the past few years, the patient has had recurrent large effusions in the left knee.Infection workup has been negative.X-rays show significant increasing osteolysis in the femur.Preoperative and postoperative diagnoses indicated failed left total knee arthroplasty secondary to polyethylene wear, massive osteolysis and femoral loosening.Description of procedure: there was significant osteolytic debris in the knee.Subtotal synovectomy was performed.The patella was everted and found to be oxidized with loss of polyethylene.There was a large cavitary defect in the inferior aspect of the patella.The patella was subluxed, knee was flexed, insert was removed.Femoral component was disimpacted from the cement mantle.At this point, the tibia was exposed circumferentially and osteolytic debris was debrided from the underneath the tibial plateau.The tibia was well fixed and was left in place.At this point, osteolytic tissue was debrided from the femur and there were large uncontained defects in the posteromedial and posterolateral condyles, worse on the medial side.The femoral and tibial insert components were revised to exactech devices.The patient was awakened and taken to recovery room in stable condition.Original description summary: it was reported via legal documentation that approximately 141 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear left side revised: premature, unnecessary revision surgery.Tissue and bones loss.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
As a result of this review, it was confirmed that (b)(4) is a duplicate of (b)(4).No additional information was received to indicate the need for a 2nd case record.Therefore, (b)(4) will be closed and the investigation of this event will be documented on (b)(4).The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening and inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening could not be confirmed from the provided information.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 were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC FEMORAL PS CEM LEFT 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19948257
• Report Number: 1038671-2024-02755
• Device Sequence Number: 20635002
• Product Code: JWH
• UDI-Device Identifier: 10885862304476
• UDI-Public: 10885862304476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 07/31/2016
• Device Catalogue Number: 02-010-01-0240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 08/03/2011
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male