MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case gregory toskos rk rev as reported via legal documentation, this 47 year old male underwent a right total knee replacement on (b)(6) 2015 for sports related severe posttraumatic arthritis.He did well initially, but approximately 2 years postoperatively, he began to present with complaints of swelling related to activity in the right knee.With exercise, skating or other activities, the knee became prominently swollen and this progressed over time so that over the last year and a half, the swelling was becoming uncomfortable and manifesting in severe stiffness and loss of motion.The patient did receive a recall letter in early 2022, and we therefore brought him in, analyzed the joint fluid, which was consistent with accelerated polyethylene wear, and infection, but very thickened and hypertrophic synovial soft tissues.The patient underwent revision right total knee replacement, tibial component with polyethylene exchange (b)(6) 2022, approximately 7 years after their initial replacement.Pre & post operative diagnosis: failed right total knee replacement secondary to premature wear of the bearing surface.Surgeon noted that the polyethylene insert showed considerable wear and delamination of the medial and lateral aspects of the implant.The femoral and tibial components were well fixed without any signs of loss of fixation and there was no osteolysis.Debridement of "exuberant and highly abnormal synovial tissues in the posterior compartment of the knee was also noted with no evidence of infection, but very thickened and hypertrophic synovial soft tissue.Patient taken to recovery room in stable condition.There were no complications during the procedure.No device return anticipated due to this being a legal case.Unable to locate ebi initial surgery, as this is an hss case.Historical record & smartsolve searched for sn/patient name with no results.No further information.2009012 02-012-35-3515 logic tibia ps mod insrt sz 3.5 15mm serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k093360.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: the revision reported in the case was likely the result of polyethylene wear as stated in the operative notes.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation, and radiographs and photographs were not provided.
Additional Manufacturer Narrative
H6: corrected health effect clinical code, medical device problem code, and type of investigation.Added component code.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, decreased range of motion, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 16769402
• Report Number: 1038671-2023-00748
• Device Sequence Number: 6378001
• Product Code: JWH
• UDI-Device Identifier: 10885862001870
• UDI-Public: 10885862001870
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2019
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3.5 15MM
• Device Catalogue Number: 02-012-35-3515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 11/15/2024
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 09/12/2023; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male