MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR FEMORAL CEM, RIGHT, SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of pain which may have been due to aseptic (non-infected) loosening of the femoral component.The lack of bone cement adhered to the femoral component may indicated an insufficient bond between the implant and the bone cement.This may have been the result of the cementing technique used or environmental conditions in the operating room during implantation, or micromotion of the femoral component relative to the cement mantle in situ.However, this cannot be confirmed as the device was not available for evaluation, and there were no details regarding cementing technique or environmental conditions provided.The most probable root cause associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Event or Problem Description
As reported, approximately 7 years postop the initial implant, the female patient was taken to the or for continued right pain in the knee and a revision was indicated.The femoral component did not appear to be loose but upon removing it with osteotomes the femur easily disassociated from the cement mental mantle.The patient was successfully revised to a cc size 3 femur with a 14 x 40 stem and distal and posterior augments of 5mm bilaterally.The doctors are unclear if the femoral component was the actual cause of the pain however upon removing it, they did feel uncomfortable with how easily it detach from the cement mantle but revision surgery was successful performed.The patient was left in stable condition.Device not returning per facility policy.

• Brand Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11229331
• Report Number: 1038671-2021-00018
• Device Sequence Number: 3446334
• Product Code: JWH
• UDI-Device Identifier: 10885862158116
• UDI-Public: 10885862158116
• 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: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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 Model Number: LOGIC CR FEMORAL CEM, RIGHT, SZ 3
• Device Catalogue Number: 02-010-03-0330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability