MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 2, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC FEMORAL SIZE 2, RIGHT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic tibia traptray cem sz 2f/2t (cat#: 02-012-41-2020 / serial#: (b)(4)), logic tibia ps mod insrt sz 2 9mm (cat#: 02-012-35-2009 / serial#: (b)(4)), three peg patella 32mm (cat#: 200-02-32).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a representative informed that on (b)(6) 2022 that a surgeons will be replacing a loose femoral stem extension screw in one of his patient's right knee.The revision to occur on (b)(6) 2022.The x-ray images provided indicate that this is a logic cc femoral component.The plan is to retain the femoral component, remove the loose screw, and replace with a new screw that they will tighten down intraoperatively.No additional information available.
Additional Manufacturer Narrative
After further review of additional information received the following sections d6b, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of not fully tightening the screw into the femoral component using the torque-limiting driver handle, which is preset to release when the appropriate torque has been achieved, allowing for the screw to back out.However, this cannot be confirmed as the screw was not returned for evaluation.The most probable root cause associated with the reported event of "disassembled/misassembled¿ is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).Section d1: brand name section d4: model number, catalog number, serial number, expiration date, unique identifier (udi) # section d9: device available for evaluation section d10: concomitants products - truliant tib imp psc insert sz 2, 13mm (cat# 02-022-44-2013 / serial# (b)(4)) - truliant tib imp psc insert sz 2, 15mm (cat# 02-022-44-2015 / serial# (b)(4)).

• Brand Name: LOGIC CC FEMORAL SIZE 2, RIGHT
• 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: 14279317
• Report Number: 1038671-2022-00515
• Device Sequence Number: 5236852
• Product Code: JWH
• UDI-Device Identifier: 10885862265708
• UDI-Public: 10885862265708
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2023
• Device Model Number: LOGIC CC FEMORAL SIZE 2, RIGHT
• Device Catalogue Number: 02-010-06-0320
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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
• Patient Sex: Unknown