MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 yrs postop the initial l tka this (b)(6) male patient presenting with complaining of swelling of his left knee for the past 2 years followed by instability and was scheduled for a revision due to increase wear on left tibial surface.Patient was last known to be in stable condition following the event.Devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, left, sz 4 (cat# 02-010-03-0240 / serial# (b)(4)).Lgc tibial fit tray cem sz 4f / 5t (cat# 02-012-45-4050 / serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 / cat# 4243255).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, left, sz 4 (cat# 02-010-03-0240 / serial# (b)(4)).Lgc tibial fit tray cem sz 4f / 5t (cat# 02-012-45-4050 / serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 / cat# 4243255).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5 yrs postop the initial l tka this (b)(6) male patient presenting with complaining of swelling of his left knee for the past 2 years followed by instability and was scheduled for a revision due to increase wear on left tibial surface.Patient was last known to be in stable condition following the event.Devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
The revision reported was likely the result of a combination of third body wear and progressive instability, which led to wear and delamination of the polyethylene insert.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 4, 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: 13006131
• Report Number: 1038671-2021-00701
• Device Sequence Number: 4848541
• Product Code: JWH
• UDI-Device Identifier: 10885862174451
• UDI-Public: 10885862174451
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 12/16/2021
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 4, 11MM
• Device Catalogue Number: 02-012-47-4011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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 Age: 65 YR
• Patient Sex: Male