MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, LEFT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-03-0225
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 02-012-51-2509 logic tib insert impl crc, sz 2.5, 9mm s058415.200-02-35 three peg patella 35mm 6630973.02-012-45-2525 lgc tibial fit tray cem sz 2.5f / 5t 6556906.
Event or Problem Description
As reported, approximately 3 years and 5 months post left total knee arthroplasty (tka), revision of the prosthesis was performed due to wear on the patella and tibial insert as well as the femur ¿debonded¿ from the cement.Everything was removed and replaced with a competitor prosthetic.There was no reported breakage of the device and no surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Report numbers: 1038671-2024-04046, 1038671-2024-04047 this follow-up report is being submitted to relay additional and/or corrected information.D10 concomitant: (b)(6) a10012 - gps implant kit v2.(b)(6) a10012 - gps implant kit v2.(b)(6) 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t.(b)(6) 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) 521-78-32 - threaded pin size 3.0 collarless.(b)(6) 02-012-51-2509 - logic tib insert impl crc, sz 2.5, 9mm.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-23 - threaded pin size 2.3 collared.The revision reported may have been the result of prosthesis wear and femoral loosening, as stated in the experience report.However, the images of the revised tibial insert do not show signs of extensive wear inconsistent with being implanted for over 3 years.The aseptic (non-infected) loosening of the femoral component may have been due to an insufficient bond at the cement-implant interface.However, potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation, and no relevant clinical information, radiographs, or images of the patella component were 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 CR FEMORAL CEM, LEFT SZ 2.5
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20495444
• Report Number: 1038671-2024-04045
• Device Sequence Number: 4209207
• Product Code: JWH
• UDI-Device Identifier: 10885862158000
• UDI-Public: 10885862158000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2026
• Device Catalogue Number: 02-010-03-0225
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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 H11; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 90 KG