MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 3.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 02-012-35-3511); tibial tray (cat# 02-12-45-3525); patella (cat# 200-02-35).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech knee replacement study, approximately six years post tka female patient (b)(6), patient experienced aseptic femoral loosening.Patient experienced increasing pain and laxity, at revision was performed for femoral component loose at implant cement interface.Wear of poly on posterior post.The event is possibly related to the device and to the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d10, g3, g6, h2 and h4 have been updated accordingly.Section d10; concomitant medical products tibial insert (cat# 02-012-35-3511 / serial# (b)(6)) tibial tray (cat# 02-12-45-3525 / serial# (b)(6)) patella (cat# 200-02-35 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported in was likely the result of both patient conditions and an insufficient bond between the femoral component and the bone, which led to aseptic(non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not able to be obtained.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• 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: 13061303
• Report Number: 1038671-2021-00728
• Device Sequence Number: 1609127
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2022

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: 09/22/2018
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• Device Catalogue Number: 02-010-01-0335
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 03/11/2022; 05/25/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 04/04/2022; 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 82 KG