MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient presented with pain and instability and was scheduled for a right revision tka possible poly swap.Upon revision, the poly insert was removed and appeared to be broken into pieces posteriorly.The poly was not intact and showed abnormal wear.The metal femur and tibia implants were well fixed, and the patient obtained a poly swap after trailing with a crc size 13mm insert, a new crc size 3.5, 13mm poly was implanted.The patient was revised from an 11mm, 3.5 ++ poly to a 13mm 3.5 crc poly.The surgeon removed and irrigated out the parts/pieces from the knee.The patient left the or room stable.The poly and its pieces were contained, saves, and will be returned to manufacturer.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, right, sz 3.5 (cat # 02-010-03-0335, serial#: (b)(4)) three peg patella 32mm (cat# 200-02-32, serial#: (b)(4)) lgc tibial fit tray cem sz 3.5f / 4.5t (cat# 02-012-45-3545, serial#: (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of a combination of axial rotation mismatch of the femoral component relative to the tibial insert, overall posterior slope of the tibial insert, and patient-related conditions, which allowed for excessive posterior contact, especially medially, and led to severe wear 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 five years.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• 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: 13362074
• Report Number: 1038671-2022-00044
• Device Sequence Number: 5058994
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/09/2022

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: 08/14/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• Device Catalogue Number: 02-012-49-3511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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: Male