MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-35-2511
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical product: (b)(6), 02-010-01-0325 - logic femoral ps cem right sz 2.5; (b)(6), 200-02-32 - three peg patella 32mm; (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk; (b)(6), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t; (b)(6), 201-78-89 - 3" drill bit, mod.Hex 2 pack; (b)(6), 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19; (b)(6), 13a2101 - cemex system fast genta 70g.
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement surgery on (b)(6) 2016 due to advanced osteoarthrosis.They underwent right knee revision surgery (b)(6) 2023, approximately 6 years 8 months after their primary procedure.According to the (b)(6) 2023 op report: the classic increased synovitis was noted.No purulence whatsoever.The synovium was thickened, polyethylene engorged synovium.This was debrided, which was significant amount.The polyethylene had some significant medial compartment wear in the posterior aspect of the tibial spine that was also significantly worn.There were some large macro cracks in the medial plateau also.The femoral component was stable when stressed.The tibial component was stable also.The patellar component was encased in some significant scar and synovitis, which was debrided.The patient tolerated the procedure well.There were no apparent intraoperative complications.All counts were correct.No breaks in sterile technique.No significant specimen.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.
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 and cracking or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 PS MOD INSRT SZ 2.5 11MM
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17240632
• Report Number: 1038671-2023-01517
• Device Sequence Number: 20032708
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• 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: 2016
• 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
• Report Date (Section B): 01/02/2025

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
• Device Expiration Date: 03/02/2019
• Device Model Number: 02-012-35-2511
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 01/01/2025
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2011
• 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
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female