MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 13MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: trapezoid tibial tray sz 3f/2t (cat# 204-04-32 / serial# (b)(4)); tibial augment block 1/2-sz 2 5mm (cat# 204-62-05 / serial# (b)(4)); stem extension 80l x12 mm (cat# 204-32-08 / serial# (b)(4)); tibial augment block 1/2-sz 2 5mm (cat# 204-62-05 / serial# (b)(4)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)); tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven years post tka, patient had a partial tibial revision for an unknown reason.This is not a pe liner issue due to non-conforming evoh bags, there is no information received any info of incident at that time, there is no complaint registered on our side.No additional information available.
Additional Manufacturer Narrative
As reported, approximately seven years post tka, patient had a partial tibial revision for an unknown reason.This is not a pe liner issue due to non-conforming evoh bags, there is no information received any info of incident at that time, there is no complaint registered on our side.No additional information available.Upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.

• Brand Name: PS TIBIAL INSERTS SZ 3, 13MM
• 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: 13172772
• Report Number: 1038671-2022-00008
• Device Sequence Number: 4562232
• Product Code: JWH
• UDI-Device Identifier: 10885862048325
• UDI-Public: 10885862048325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 04/21/2016
• Device Model Number: PS TIBIAL INSERTS SZ 3, 13MM
• Device Catalogue Number: 204-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2008
• 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; Required Intervention
• Patient Sex: Unknown