MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal team, approximately 6.5 years post initial right tka, the husband of the (b)(6) female patient reported that the patient¿s right knee was initially implanted and patient seemed to recover well from the procedure, except that the scar was large.The patient started experiencing pain and swelling for ¿awhile¿ before she was returned for a revision with competitor¿s devices.It was noticed during the revision that the patient¿s femoral component was loosening.The wound was cultured for infection and came back negative.There was no breakage of device and no surgical delay/prolongation.The patient experienced a long, severely painful recovery and still is not ambulatory, she uses a wheelchair or a walker and ¿severe scarring¿.¿she is terrified of the thought of having another surgery.¿ sales rep was unable to obtain photos/x-rays.The device is not available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: logic tibia implant psc insert, sz 2.5, 11mm (cat# 02-012-44-2511 / serial# (b)(4)) ,lgc tibial fit tray cem sz 2.5f / 2.5t (cat# 02-012-45-2525 / serial#(b)(4)) , and three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the revision reported was likely the result of aseptic (non-infected) loosening of the femoral component, which damaged bond of the implant to the bone and likely led to the reported pain.However, this cannot be confirmed because the components were not returned for evaluation and no x-rays were provided.The most probable root cause associated with the reported event of "loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: g3, h2, and h3.H3: the revision reported was likely the result of aseptic (non-infected) loosening of the femoral component, which damaged bond of the implant to the bone and likely led to the reported pain.However, this cannot be confirmed because the components were not returned for evaluation and no x-rays were provided.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13795945
• Report Number: 1038671-2022-00265
• Device Sequence Number: 17151105
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2023

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: 10/11/2017
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 09/01/2022; 05/12/2023
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 09/26/2022; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female