MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	02-012-35-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 2579797 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, 2643824 02-012-35-3509 - logic tibia ps mod insrt sz 3.5 9mm, 2842184 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, 2843046 02-010-01-0235 - logic femoral ps cem left sz 3.5, 2945721 02-010-01-0335 - logic femoral ps cem right sz 3.5, 2993769 200-02-32 - three peg patella 32mm, 3609655 200-02-32 - three peg patella 32mm, 3612440 201-78-89 - 3" drill bit, mod.Hex 2 pack, 38024 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19, aa7196 1500-s - cemex system 80g, aa7229 asa0030 - sterile disposable containers, aa7857 asa0030 - sterile disposable containers.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2014.Approximately 8 years and 5 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022.Principal diagnosis: failed right total knee replacement due to mechanical loosening.Post-op diagnosis: same.Significant fibrinous debris was encountered into the joint with a tandem whitish color this tissue was highly friable was found throughout the suprapatellar pouch as well as in the gutters.This was excised and the knee in order to fully debrided to visualize all the components then removes similar debris from the anterior interval as well as did are normal medial release.We then removed the polyethylene insert with a single prong retractor.The poly was noted to be yellow with significant pitting and loss of thickness in the medial lateral compartment with central pitting and roughness noted on both the medial and lateral dwell points.The femoral implant was grossly loose and was removed without any machine and.Similar fibrous debris was found under the femoral component and into the posterior lateral.This was debrided with sharp dissection as well as with the rongeur bluntly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, tibial loosening, and femoral loosening could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17684050
• Report Number: 1038671-2023-02153
• Device Sequence Number: 2608716
• Product Code: JWH
• UDI-Device Identifier: 10885862001849
• UDI-Public: 10885862001849
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: 02-012-35-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 09/30/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male