MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0320
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification february 2023, that a patient underwent initial right tkr on (b)(6) 2017 and was implanted with exactech devices in the right knee.The arthroplasty was done correctly and did not deviate from accepted medical custom and practice with regards to the implantation of the exactech devices.On or around on (b)(6) 2022, patient received a letter informing of devices recalled by exactech.After an mri was performed on right knee, patient was advised that the knee replacement failed for reasons related to the defective device.As a result, the patient underwent revision surgery on right knee on (b)(6) 2022, approximately 5 years post initial procedure, for issues including but not limited to polyethylene wear, bone loss, osteolysis, and/or component loosening.Patient experiences daily pain and discomfort in her knee which limits her activities of daily living and impacts her quality of life.Further reported on (b)(6) 2024, the patient presents with a painful and unstable right knee replacement.The patient was noted to have aseptic loosening of the femoral component and marked osteolysis.The patient has failed conservative management including activity modification, anti-inflammatory medications, and injections.All options were discussed in detail with the patient and they decided to proceed with revision right total knee replacement.The surgeon reports "the patella was subluxated laterally.There was very extensive synovitis and a very thorough synovectomy of the joint was performed.The polyethylene liner was removed.There was noted to be wear of the liner with delamination.Next the femoral component was noted to be loose and it was removed.There was significant fibrous tissue beneath it with marked osteolysis.[the patella was noted to be well fixed, but there was some wear on the patella.]" no device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
(d10) concomitant devices: 02-012-41-2010 - logic tibia traptray cem sz 2f/1t: (b)(6), 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm: (b)(6), 200-02-29 - three peg patella 29mm: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00350.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, or due to inclusion of the polyethylene in the packaging recall.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21086195
• Report Number: 1038671-2025-00101
• Device Sequence Number: 6831954
• Product Code: JWH
• UDI-Device Identifier: 10885862001214
• UDI-Public: 10885862001214
• 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: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 04/18/2022
• Device Catalogue Number: 02-010-01-0320
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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: 75 YR
• Patient Sex: Female