MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department the patient had an initial right knee replacement in (b)(6) 2018.Approximately 4 years and 8 months after the initial surgery, the patient had a right knee revision on (b)(6) 2022 due to accelerated and preventable wear.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Event or Problem Description
Additional information received via legal department - revision report of (b)(6) 2022 for failed right total knee replacement secondary to wear of the bearing surface.The patient began to experience swelling, pain, and knee stiffness.The synovial fluid in the preoperative period was analyzed; it was consistent with a reaction to polyethylene debris with very high lymphocyte-monocyte count.At surgery there was exuberant synovial expansion to a moderate degree.The polyethylene showed surface scratching and the surface had the appearance of being oxidized.Sterile dressings were applied; the patient was awakened and taken to the recovery room in stable condition.There were no complications during the surgical procedure.No additional information is available.
Additional Manufacturer Narrative
Pending investigation correction - f10-should be blank.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and/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 TIBIA IMPLANT PSC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16794382
• Report Number: 1038671-2023-00799
• Device Sequence Number: 7508393
• Product Code: JWH
• UDI-Device Identifier: 10885862173508
• UDI-Public: 10885862173508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: 04/14/2025
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-44-2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/25/2023; Not provided
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/25/2023; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female