MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS POR LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-02-0230
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Joint Laxity (4526); Joint effusion (4849)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 4818505 02-012-44-3011 - insert tibial logic fixe psc t3/11mm.5241864 - 02-012-45-3040 - embase tibiale fit logic cimentee 3f/4t.5893383 - 200-02-41 - implant patellaire 3 plots.5705289 - 204-34-04 - tige extension diam 14 lg 40.5743666 - 04-70-00 - vis pour tige extension tibiale.2028019157 - a10012 - gps implant kit v2.
Event or Problem Description
It was reported that a male patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 8 months post the initial procedure.The patient was suffering from laxity, instability, and chronic hydroarthrosis.Macroscopic pe granuloma indicated.The report stated the patient had aseptic tibial and femoral loosening 5 years after the initial placement.The pe was changed.No surgical delays or device breakages were reported.No x-rays were provided.The device return status for analysis is unknown currently.They have been requested.No device images were provided.No further information.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and insufficient bonds between the components and the bones, which led to aseptic (non-infected) femoral and tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
H6: corrected medical device problem code.

• Brand Name: LOGIC FEMORAL PS POR LEFT SZ 3
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19122445
• Report Number: 1038671-2024-00880
• Device Sequence Number: 18200171
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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: 05/15/2024
• Device Catalogue Number: 02-010-02-0230
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/29/2024; 07/29/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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
• Patient Sex: Male