MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2021
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 3.5 years postop her right tka, this (b)(6) y/o overweight female was scheduled for a revision due to the poly insert was worn.Surgeon removed and replaced the 11+ insert and implanted a 17mm crc insert in its place.Outcome is unknown at this point.The device will be returned for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been due to the orientation of the knee components, third body wear, and/or patient related conditions which led to wear of the tibial insert.Additionally, a contributing factor may have been being packaged in a nonconforming vacuum bag for more than five years before being implanted.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 11629780
• Report Number: 1038671-2021-00159
• Device Sequence Number: 19807817
• Product Code: JWH
• UDI-Device Identifier: 10885862174291
• UDI-Public: 10885862174291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 11/29/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 2, 11MM
• Device Catalogue Number: 02-012-48-2011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female