MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-6011
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: 2312320; 02-010-01-0360 - logic femoral ps cem right sz 6.3859226; 02-012-45-6050 - lgc tibial fit tray cem sz 6f / 5t, 4060041; 200-02-38 - three peg patella 38mm.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2015 and then approximately 8 years later on (b)(6) 2023 experienced a surgical revision.Revision operative report of (b)(6) 2023 -postoperative diagnosis- failed right total knee/revision right total knee (tibial, femoral and polyethylene components).Patient was revised to competitor's devices.Findings: loose femoral implant- removed easily with moderate bone loss.Excessive wear of polyethylene with signs of oxidation/yellow discoloration, pitting, cracking and delamination of the poly.Distal femoral bone loss was moderate.The tibial bone loss was extensive and repaired with tibial cone.Patella button was stable and not revised.Patient was taken to pacu in stable condition.There is no other patient or medical information provided.No device return.There is no other information available.
Additional Manufacturer Narrative
Report number: 1038671-2024-04518 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h10.The following sections were corrected: b2- both hospitalization - initial or prolonged and required intervention to prevent permanent impairment/damage (devices).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, cracking, and 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, cracking, and 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 TIBIA IMPLANT PSC INSERT, SZ 6, 11MM
• 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: 18990478
• Report Number: 1038671-2024-00686
• Device Sequence Number: 2946735
• Product Code: JWH
• UDI-Device Identifier: 10885862173843
• UDI-Public: 10885862173843
• 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: 2015
• Device Explanted Year: 2023
• 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): 11/27/2024

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: 12/17/2020
• Device Catalogue Number: 02-012-44-6011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 11/21/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 11/26/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2012
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male