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

Catalog Number	02-012-49-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2019 and subsequently began experiencing swelling and pain in the operative knee.The patient's symptoms continued for an additional 3.5 years.The patient followed up with his orthopedic surgeon and had radiographs taken, which revealed asymmetric polyethylene wear.Ct was then performed to ensure the implant was not metal on metal.The patient scheduled for a revision and taken to the operating room.Exposure was made through the existing tka incision.Extensive amounts of synovitis could be observed in all compartments of the knee.Polyethene debris could be observed floating freely within the joint.Polyethylene liner was removed.Polyethylene liner had near completely worn off the posterior medial edge and oxidization could be seen on the polyethene liner.Major synovectomy was performed.A new poly was placed in the tibial tray and the patient's wound was closed.All fragments, parts or pieces were removed by the surgeon.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
Revision op report on (b)(6) 2023 diagnosis: polyethylene of right knee prosthesis there is very significant synovitis in the medial gutter and the lateral gutter proximal of the patellofemoral joint and anterior to the medial joint and anterior to the lateral joint line.It had a very hypertrophic appearance.The polyethylene component came out.It was very worn both medially and laterally.The patient was transferred to gurney and taken to the recovery room.There is no other information available.
Additional Manufacturer Narrative
D10.Concomitants: 02-010-03-0340 - logic cr femoral cem, right, sz 4, sn 5726275 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, sn (b)(6) - three peg patella 32mm, sn (b)(6).H3- pending investigation.No other information available.H11.Correction ¿ f10 should be blank.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and prosthesis fracture.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause for the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear and prosthesis fracture.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17393944
• Report Number: 1038671-2023-01769
• Device Sequence Number: 14941184
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• 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
• Serviced by Third Party (Y/N): N
• 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): 01/16/2025

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: 09/25/2020
• Device Catalogue Number: 02-012-49-4009
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 04/30/2024; 05/03/2024; 01/16/2025
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 04/30/2024; 05/09/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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: 61 YR
• Patient Sex: Male