MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number 02-012-44-5011

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via a legal notification, that a male patient, initial left knee implanted with an optetrak logic ps tibial insert, size 5, 11mm on (b)(6) 2015, underwent a revision procedure on (b)(6) 2022, approximately 7 years 1 month post the initial procedure.During the revision surgery, a substantial amount of osteolysis and implant loosening was noted.Upon information and belief, the loose components and osteolysis in plaintiff¿s left knee was due to premature polyethylene wear of the tibial insert.Following the revision surgery, plaintiff continues to be limited in his activities of daily living.Plaintiff has difficulty with daily activities such as getting dressed, climbing stairs, and bathing.Despite undergoing the revision surgery, the plaintiff experiences daily pain and discomfort in his knee which limits his activities of daily living and impacts his quality of life.No device return anticipated due to this being a legal case.No further information.

Manufacturer Narrative

Additional information - e3, e4.H6.Investigation results - the revision reported may have been due loosening, osteolysis, and polyethylene wear.The loosening/osteolysis may have been the result of an insufficient bond between the knee components and the bones.The root cause of the reported wear cannot be determined as the explanted devices were not returned for evaluation and images of the explanted device/radiographs were unable to be obtained.These devices are used for treatment not diagnosis.There is no other information available.Correction-e1 -facility name.

Manufacturer Narrative

Product has been identified.As a result, the following fields have been updated: d1, d4, h4, h7, and h9.Any additional information and/or investigation results will be provided within 30 days of receipt.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM
• 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 ; 3523771140
• MDR Report Key: 16242346
• MDR Text Key: 308112127
• Report Number: 1038671-2023-00069
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173720
• UDI-Public: 10885862173720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Catalogue Number: 02-012-44-5011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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: Male