MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately three years post initial left tka, the male patient was suffering from laxity and pain.Patient had a revision surgery an early granuloma on pe synovectomy was performed, liner pe changed.There was no breakage of device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H10.Related- mfr #1038671-2024-02590 report 1 of 2.H11.Additional manufacturer narrative- report 1 of 2.Additional information added.D10.Concomitants: sn (b)(6) - cat #02-010-02-0235.Sn (b)(6) - cat #02-012-45-3535.Sn (b)(6) - cat #200-02-35.Sn (b)(6) - cat #204-34-04.Sn (b)(6) - cat #204-70-00.H3.Investigation results- photo: posterior tibial spine wear is likely to occur when the post is chronically subjected to higher-than-normal shear forces and/or rapid, rather than gradual engagement of the femoral cam with the tibial insert spine during knee flexion.The damage on the tibial spine suggests that there may have been some level of knee instability.Instability occurs when the soft-tissue structures around the knee are unable to provide the stability necessary for adequate function during standing or walking.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.Pain and/or a sense of ¿giving away¿ of the knee may alter knee function and require revision surgery.The frequency of occurrence ranking is "very low".The tibial insert was packaged for approximately 5.42 years before being implanted.Risk documents were reviewed, risks are captured.The revision reported was likely the result of tibial insert wear and instability.Additionally, a contributing factor to the reported wear of the tibial insert may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, the extent and likely cause of the prosthesis wear and instability could not be determined as the devices were not returned for evaluation, and radiographs and images of the patella were not provided.These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
Revision operative report - painful synovitis and laxitis of the left knee.Removal of total left knee prosthesis by synovectomy and insert change.Synovectomy.The insert shows signs of microscopic wear.Moderate balanced patellar wear.The "ball joint is not loose".The ¿anchoring¿ of the tibial and femoral components was performed and noted to be ¿perfect¿.There were no difficulties or unforeseen events noted.Patient to begin rehabilitation post operatively.Patient outcome was not provided.There is no additional information available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19160079
• Report Number: 1038671-2024-00935
• Device Sequence Number: 20697055
• Product Code: JWH
• UDI-Device Identifier: 10885862173591
• UDI-Public: 10885862173591
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• Device Catalogue Number: 02-012-44-3509
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male