MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: concomitant medical products: 3 peg 29mm patella, size 3 tibial baseplate, size 3 ps femoral knee.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by legal brief, on or about (b)(6) 2014, patient underwent a left total knee replacement surgery in which an optetrak system was implanted to treat left knee degenerative joint disease.After implantation patient experienced pain and other symptoms and was ultimately diagnosed in 2021 with failed left total knee arthroplasty.On (b)(6) 2022, as a direct and proximate result the patient required left total knee revision surgery to remove failed device and replace it with a new total knee replacement system.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, g3, g4, g6, h2, h3, h4, h6 and h9 have been updated accordingly.Section d10: three peg patella 29mm (cat# 200-02-29 / serial# (b)(6)).Holding pin headed long 2 pack (cat# 201-78-10 / serial# (b)(6)).Trapezoid tibial tray sz 3f/3t (cat# 204-04-33 / serial# (b)(6)).Optetrak asy,ps cemented femoral, sz 3, (cat# 234-02-03 / serial# (b)(6)).(h3) as reported by legal brief, on or about september 22, 2014, patient underwent a left total knee replacement surgery in which an optetrak system was implanted to treat left knee degenerative joint disease.After implantation patient experienced pain and other symptoms and was ultimately diagnosed in 2021 with failed left total knee arthroplasty.On january 4, 2022, as a direct and proximate result the patient required left total knee revision surgery to remove failed device and replace it with a new total knee replacement system.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: PS TIBIAL INSERTS SZ 3, 9MM
• 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: 14649321
• Report Number: 1038671-2022-00665
• Device Sequence Number: 19811865
• Product Code: JWH
• UDI-Device Identifier: 10885862048301
• UDI-Public: 10885862048301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2017
• Device Model Number: PS TIBIAL INSERTS SZ 3, 9MM
• Device Catalogue Number: 204-23-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female