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	02-012-49-1509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, six years after the initial left tha surgery, the 64 year old female patient complained of knee swelling and pain.The surgeon diagnosed wear of the tibial insert and a revision was performed on an unknown date.Breakage and wear was observed in the retrieved tibial insert.No metallosis was found.There was no problem with the locking mechanism of the tibial tray.All proliferative tissue was removed and only the tibial insert was replaced.All parts/pieces were removed from the patient.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: 02-010-03-0215 - (b)(6)- logic cr femoral cem, left sz 1.5 a10012 - 111040017008 - gps implant kit v2.
Additional Manufacturer Narrative
H2: the revision reported, may have been the result of rotational mismatch between the femoral and tibial components and mechanical overload on the medial posterior edge of the tibial insert.Which, led to wear and/or fracture of the polyethylene insert.Contributions from the overall posterior tibial slope and potential ligamentous imbalances may have allowed for the excessive posterior contact.However, this cannot be confirmed, since the device was not available for evaluation.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years.Which may have contributed to the reported wear and/or fracture.Based on the images provided, it is unclear if the tibial insert was fully seated.Which, could have been another contributing factor.Additional information: h6: clinical codes.

• 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: 19219940
• Report Number: 1038671-2024-01021
• Device Sequence Number: 18192310
• Product Code: JWH
• UDI-Device Identifier: 10885862144409
• UDI-Public: 10885862144409
• 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: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 02-012-49-1509
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 92 KG