MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number 02-012-45-4040

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

Concomitants: 02-010-06-0240 - logic cc femoral size 4, left.02-012-60-1440 - logic stem ext 14mm x 40mm 200-02-29 - three peg patella 29mm.02-012-61-4222 - logic off stm ext 22mm x 120l x 4mm offset.02-010-06-0541 - logic post.Aug.Block size 4, 5mm.208-05-04 - cc distal fem augment sz 4, 5mm.

Event Description

It was reported via clinical study, that the 52 yo white female patient experienced (tibial implant subsidence/migration) tka tibial comp loosening / subsidence and associated varus deformity.The date of onset is (b)(6) 2022.The patient underwent revision surgery.Indication for revision surgery is aseptic, loosening.The patient¿s outcome was last known as continuing.

• Brand Name: OPTETRAK LOGIC
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16541954
• MDR Text Key: 311291560
• Report Number: 1038671-2023-00436
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-45-4040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White