MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 5F/4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRAPEZOID TIBIAL TRAY SZ 5F/4T
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)) and ps tibial inserts sz 5, 9mm (cat# 204-25-09 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately thirteen years post initial left tka, this (b)(6) patient was having painful knee and came to surgeon with discomfort and swelling.Upon evaluation surgeon felt a liner exchange would help.Intra operatively surgeon found metallosis and a man hole cover that came disconnected from the tibia.It was stuck between the liner and proximal tibia tray.Also the patella had some wear to it.There was no osteolysis.So surgeon replaced it.Surgeon placed a 5/11mm ps and revised the patella to a 38mm.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
(h3 the revision reported was likely the result detachment of the tibial tray¿s man hole cover and patella wear.It is possible that the posterior, lateral man hole cover detached from the tray upon implantation/cementation.This may have prevented the lateral side of the insert from fully seating, which led to micromotion between the tibial insert and tibial tray.Over time, the micromotion wore away the locking button, leading to more motion, which ultimately resulted in backside wear, metallosis, and pain after being implanted for over 12 years.The most probable root cause associated with the reported event of ¿detachment of device or device component¿ is associated with the separation of the device from its physical construct, integrity, or chassis.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• 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: 14118194
• Report Number: 1038671-2022-00417
• Device Sequence Number: 4399376
• Product Code: JWH
• UDI-Device Identifier: 10885862047717
• UDI-Public: 10885862047717
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 07/26/2023

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: 03/12/2014
• Device Model Number: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• Device Catalogue Number: 204-04-54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2022
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2009
• 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: 66 YR
• Patient Sex: Male