MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-6011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 07012016043 a10012 - gps implant kit v2 4061331 02-010-01-0260 - logic femoral ps cem left sz 6 4215568 200-02-41 - three peg patella 41mm 4300137 02-012-45-6060 - lgc tibial fit tray cem sz 6f / 6t 5x225 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2017.Approximately 6 years and 4 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.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) 2023 diagnosis: failed total left knee there was diffuse synovial proliferation with tan-colored and hypervascular staining to the synovial lining of the joint.The polyethylene liner was locked in the tibial tray, and there was minimal wear of the articular surface of the liner (medial corner of posterolateral articular aspect, mild lateral post erosive wear, undersurface intact) as well as grooving and delamination on the lateral aspect of the patellar button.The femoral component debonded from the cement with ease.There was a large uncontained defect anteriorly.The patient was taken to the recovery room in satisfactory condition.
Additional Manufacturer Narrative
1038671-2024-04340, 1038671-2024-04338.H6: corrected the following: health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions.The reason for the revision reported in cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 6 11MM
• Common Device Name: 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 ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18121058
• Report Number: 1038671-2023-02756
• Device Sequence Number: 7609341
• Product Code: JWH
• UDI-Device Identifier: 10885862001979
• UDI-Public: 10885862001979
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 04/01/2021
• Device Catalogue Number: 02-012-35-6011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2013
• 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: 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 Sex: Male