MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately thirteen years post initial right tka, this (b)(6) male patient had a revision due to increase wear of the polyethylene insert.There was no breakage of the device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
Concomitant medical products three peg patella 41mm (cat# 200-02-41 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) the revision reported was likely the result of a combination of axial rotation mismatch of the femoral component relative to the tibial insert and patient conditions resulting in high contact stress that led to wear and cracking of the polyethylene.Additionally, a contributing factor to the severe wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than 5 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 5, 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: 14308082
• Report Number: 1038671-2022-00348
• Device Sequence Number: 20177535
• Product Code: JWH
• UDI-Device Identifier: 10885862174628
• UDI-Public: 10885862174628
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 03/13/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM
• Device Catalogue Number: 02-012-49-5011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: - LGC TIBIAL FIT TRAY CEM SZ 5F / 6T; - LOGIC CR FEMORAL CEM, RIGHT, SZ 5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 136 KG