MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial tka, the female patient returned to the clinic complaining of pain.A mri showed synovitis and x-ray showed asymmetric wear.A revision was performed and the components were secure with no signs of loosening.The knee was washed out and a new 12 mm crc insert was implanted.The knee was stable with good range of motion (rom).Surgeon stated that the original insert was bad with significant damage to articulate surface.Patient last known to be in stable condition.Photo received.The explant has not been released for return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of the patient¿s pain, which may have been due to prosthesis wear of the tibial insert related to third body wear and/or unreported patient conditions.This cannot be confirmed because no x-rays were provided, and the revised insert was not returned to exactech for evaluation.Additionally, a contributing factor to the wear may have been the result of the insert being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14403931
• Report Number: 1038671-2022-00550
• Device Sequence Number: 14854738
• Product Code: JWH
• UDI-Device Identifier: 10885862174390
• UDI-Public: 10885862174390
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 10/26/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
• Device Catalogue Number: 02-012-48-3011
• 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: 04/25/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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: - HOLDING PIN HEADLESS 3" (4 PK); - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; - LOGIC CR FEMORAL CEM, RIGHT, SZ 3; - LPI COLLAR DRILL; - SAW GUIDE HOLDING DRILL 1/8 X 5; - THREE PEG PATELLA 35MM
• Patient Sex: Female