MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 10/07/2022

Event Type  Injury  

Event Description

As reported by the legal brief, on (b)(6) 2016 patient underwent a left total knee replacement surgery and was implanted with an optetrak device, including an insert made of polyethylene.Patient underwent revision surgery of her left knee on (b)(6) 2022.

Manufacturer Narrative

Concomitant medical products: logic cr femoral cem, left, sz 3 (cat#: 02-010-03-0230 / serial#: (b)(4).Lgc tibial fit tray cem sz 3f / 3t (cat#: 02-012-45-3030 / serial#: (b)(4).Three peg patella 29mm (cat#: 200-02-29 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

Revision was approximately 6 years 4 months, post implant.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Additional information: b5, h6 investigation codes.H6.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.H11.G2.Health care provider.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
• Type of Device: 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: 16264849
• MDR Text Key: 308382051
• Report Number: 1038671-2023-00081
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862174383
• UDI-Public: 10885862174383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
• Device Catalogue Number: 02-012-48-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female