MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LINER
Medical Device Problem Codes	Crack (1135); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 58 y/o male patient had a primary tka in the right knee done approximately 5 years ago.Over the past 1-2 years patient has had worsening right knee pain as well as swelling that began to negatively impact his adls.Initially patient go with it however is finally seen by his orthopedic dr.For the concerns of swelling and worsening right knee pain while being more than 4 years out from surgery.X-rays were obtained which revealed bilateral joint space narrowing worse in the medial compartment when compared to the lateral however upon comparison of x-rays previously taken there was certainly narrowing in both the medial and lateral compartments.Initial lab work was done in efforts to rule out an infection.Initial lab work was not concerning for an infection and a right total knee arthroplasty revision with a polyethylene exchange was scheduled.The patient was taken to the operating room for a right total knee arthroplasty revision with a polyethylene exchange.Incision was made through the old tka incision.Upon making the arthrotomy incision copious amounts of straw-colored joint fluid with some plastic debris began flowing out of the joint.In addition to this there was severe synovitis surrounding the joint in the periosteum both medial lateral and superior.The surgeon recalled that this is the worst synovitis he has seen.The polyethylene liner was then removed.The posterior medial corner of the polyethylene liner had fallen off and there was a crack in the posterior lateral corner of the polyethylene liner.Significant oxidization could be seen on the surface of the polyethylene liner with rapid where both in the medial and lateral aspects of the liner.Upon further exposing the knee, a 0.5 cm x 4 cm polyethylene fragment was found in the posterior aspect of the knee and was then removed.A new 11 mm polyethylene liner was placed in the knee, and stability was achieved.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or photos received.The device will be return.
Event or Problem Description
X-rays were obtained which revealed bilateral joint space narrowing worse in the medial compartment when compared to the lateral however upon comparison of x-rays previously taken there was certainly narrowing in both the medial and lateral compartments.Initial lab work was done in efforts to rule out an infection.Initial lab work was not concerning for an infection and a right total knee arthroplasty revision with a polyethylene exchange was scheduled.Upon making the arthrotomy incision copious amounts of straw-colored joint fluid with some plastic debris began flowing out of the joint.In addition to this there was severe synovitis surrounding the joint in the periosteum both medial lateral and superior.The surgeon recalled that this is the worst synovitis he has seen.The polyethylene liner was then removed.The posterior medial corner of the polyethylene liner had fallen off and there was a crack in the posterior lateral corner of the polyethylene liner.Significant oxidization could be seen on the surface of the polyethylene liner with rapid where both in the medial and lateral aspects of the liner.Upon further exposing the knee, a 0.5 cm x 4 cm polyethylene fragment was found in the posterior aspect of the knee and was then removed.A new 11 mm polyethylene liner was placed in the knee, and stability was achieved.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or photos received.
Additional Manufacturer Narrative
D10.Concomitants: 02-010-03-0340 - logic cr femoral cem, right, sz 4 5726241.02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 5877369.200-02-35 - three peg patella 35mm 5711132.H3: investigation results - the most likely cause for the revision is prosthesis wear secondary to potential issues with implant alignment, insert seating at the time of implantation, and/or patient conditions.A contributing factor to the extent of wear on the returned device may be the result of being packaged in a non-conforming bag for more than 5 years.The individual contributions of each factor to the sequence of events cannot be determined due to the extent of damage and limited information regarding the initial surgery.
Additional Manufacturer Narrative
Correction: h6 clinical codes.Additional information: h6 problem codes and component code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: health effect clinical code, type of investigation, medical device problem code, investigation findings, investigation conclusions.The most likely cause for the revision is prosthesis wear, cracking and fracture secondary to potential issues with implant alignment, insert seating at the time of implantation, and/or patient conditions.A contributing factor to the extent of wear on the returned device may be the result of being packaged in a non-conforming bag for more than 5 years.The individual contributions of each factor to the sequence of events cannot be determined due to the extent of damage and limited information regarding the initial surgery.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17332223
• Report Number: 1038671-2023-01670
• Device Sequence Number: 7613776
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: LINER
• Device Catalogue Number: 02-012-49-4011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 01/30/2024; 08/21/2024; 05/15/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 02/06/2024; 09/04/2024; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 58 KG