MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-1509
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 76 year old female patient had an initial left tka on (b)(6) 2019.5 years later, the patient complained of knee swelling and pain.The surgeon diagnosed wear of the tibial insert and the patient was revised on (b)(6) 2024.Breakage and wear were observed in the retrieved tibial insert.The surgeon did not find metallosis.There was no problem with the locking mechanism of the tibial tray.Polyethylene particles and all proliferative tissue was removed and the insert was replaced to a new cr 9mm.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.D10: 5624696 - 02-010-03-0215 - logic cr femoral cem, left sz 1.5 5634363 - 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t (b)(6) - 02-012-48-1509 - logic cr tib insert slope +, sz 1.5, 9 mm 11015018037 - (b)(6) - gps disposable kit 934061.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses, 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.However, this could not be confirmed as the device was not returned for evaluation.Additional information: h6 clinical code and medical device problem code.

• Brand Name: LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19256301
• Report Number: 1038671-2024-01072
• Device Sequence Number: 15076329
• Product Code: JWH
• UDI-Device Identifier: 10885862144379
• UDI-Public: 10885862144379
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 08/01/2019
• Device Catalogue Number: 02-012-48-1509
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG