MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-012-35-2011

Device Problems Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Cyst(s) (1800)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.These devices are used for treatment not diagnosis.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a left total knee arthroplasty on 10 oct 2011 and then approximately 10 years 3 months later, on (b)(6) 2021 she experienced a surgical revision.Revision operative report of (b)(6) 2021- postoperative diagnosis: loose plastic spacer, debris synovitis, stable femur, stable tibia, stable patella with local cystic formation in tibia.Name of operation: arthrotomy, evaluation knee replacement, revision spacer, partial synovectomy, removal of debris synovitis, removal of scar tissue.The patient had gross debris synovitis throughout the knee.The plastic spacer was loosened when the knee was put into flexion; it was removed.The patient did have side-to-side play consistent with plastic debris wear.The tibia, the femur and the patella were all stable.They were not loose by mechanical evaluation and visual inspection.The patient did however have two areas on the tibia where were erosion of the cortex, one medial and one anterior with bone in between intact.The femur and patella did not show the same phenomenon.It was elected to just change the plastic spacer from an 11 to a 13.There were no intraoperative complications.No other patient information/medical history reported.No images or photos of the device are provided.The device will not be returned.No other information is available.

Manufacturer Narrative

H11.Correction- after investigating, this has been discovered to be a duplicate case.All new and additional information will be appropriately captured and reported under mfr# 1038671-2022-00031.

• Brand Name: LOGIC TIBIA PS MOD INSRT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18983568
• MDR Text Key: 338660949
• Report Number: 1038671-2024-00670
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001733
• UDI-Public: 10885862001733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033883
• 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
• Report Date: 05/22/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: 02-012-35-2011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female