MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Osteolysis (2377); Inadequate Osseointegration (2646); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2011, and then experienced a revision surgical procedure on (b)(6) 2017, approximately 6 years, 9 months after initial implant.Upon the revision of the exactech device, signs of delamination oxidation and wear of the tibial polyethylene were observed.Signs that the femoral component was grossly loose, and massive destruction and loss of the femoral bone, posterior condyles, and distal condyles were also observed.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H10.D10.Concomitants -product information: 1826511 02-010-01-0335 - logic femoral ps cem right sz 3.5; 1848791 02-012-39-3535 - logic tibia fintray cem sz 3.5f/3.5t; 1916141 200-02-38 - three peg patella 38mm pending investigation.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g4, h6.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h10, h11.The complaint device was evaluated, and the reported event was partially confirmed.The evaluation identified the insert showed scratches and pitting, which appear consistent with third body wear.Discoloration observed appeared consistent with signs of delamination.The deformation on the medial edge of the insert, appears consistent with either articulating with bone or bone cement overhanging the femoral component or femoral subsidence which allowed for bony overhang to rub against the articular surface of the insert.The deformation on the top of the post, appears consistent with damage caused by bone cement overhanging the femoral cam.Small deformation marks throughout the backside of the tibial insert which appears consistent with micromotion between the tibial insert and the tibial tray.The returned femoral component showed minimal bone cement adhesion on the femoral component.This can indicate loosening, which is consistent with the reported event.According to the information provided, the cement was sufficiently fixated on the femoral bone.When the cement was removed during the revision surgery, ¿there was massive destruction and loss of femoral bone, with just a shell of cortices medial and lateral, complete loss of the posterior condyles, and major loss of the distal condyles.¿ this may be a result of a possible cement allergy.The returned tibial tray was observed to have small deformation marks throughout the superior surface which appear consistent with micromotion between the tibial insert and the tibial tray.The remaining cement and residue appeared consistent with implantation and sufficient fixation between the implant ¿ bone cement ¿ bone interface.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of a combination of patient conditions, prosthesis wear, instability, and an insufficient bond between the femoral component and the bone, which led to femoral loosening.The prosthesis wear was able to be confirmed from the returned tibial insert; however, the reported instability and loosening could not be confirmed as serial radiography was not available should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM
• 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 FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18739627
• Report Number: 1038671-2024-00267
• Device Sequence Number: 20432061
• Product Code: JWH
• UDI-Device Identifier: 10885862001849
• UDI-Public: 10885862001849
• 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: 2011
• Device Explanted Year: 2017
• 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): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2015
• Device Catalogue Number: 02-012-35-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/26/2024; 04/02/2026
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 01/07/2025; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2010
• 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
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown