MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-49-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 4839357 02-010-04-0325 - logic cr femoral por, right, sz 2.5.5500300 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t.Credit to logic 200-00-00 - knee item-misc.4855281 200-02-35 - three peg patella 35mm.5501119 201-78-15 - holding pin mini sharp point 4 pk.5446937 201-78-81 - 3 trocar, mod.Hex 2pk.5410044 521-78-23 - threaded pin size 2.3 collared.5410045 521-78-23 - threaded pin size 2.3 collared.5410065 521-78-32 - threaded pin size 3.0 collarless.6035018122 a10012 - gps implant kit v2.H7: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient's liner and patella were revised on (b)(6) 2023 due to poly wear.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear of the tibial insert and patella possibly due to malalignment between the implants, high contact stresses during knee flexion/extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.The cause of the prosthesis wear cannot be determined because minimal information was provided, the revised components were not returned for evaluation, and no initial post-operative radiographs were provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17044542
• Report Number: 1038671-2023-01209
• Device Sequence Number: 8739165
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: 02-012-49-2509
• Device Catalogue Number: 02-012-49-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 09/30/2026
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/23/2023; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female