MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 11MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cc posterior fem augment sz 2, 5mm (cat# 208-07-02 / serial # (b)(4)), cc distal fem augment sz 2, 10mm (cat # 208-06-02 / serial # (b)(4)), three peg patella 35mm (cat # 200-02-35 / serial # (b)(4)), cc posterior fem augment sz 2, 5mm (cat # 208-07-02 / serial # (b)(4)), fluted stem extension 80l x 14 mm (cat# 204-34-08 / serial # (b)(4)), cc femoral sz 2 (cat# 208-01-02 / serial # (b)(4)), cc distal fem augment sz 2, 10mm (cat # 208-06-02 / serial # (b)(4)), cc stem ext adaptor 5 degree (cat # 208-09-05 / serial # (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately four years post tka, patient had a revision for an unknown reason.It is unknown if this is a second time revision for the same side.It is also unknown why cc insert out of scope.No additional information available.
Additional Manufacturer Narrative
After further review of additional information received.(h3) as reported, approximately four years post tka, patient had a revision for an unknown reason.It is unknown if this is a second time revision for the same side.It is also unknown why cc insert out of scope.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, 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: 13172927
• Report Number: 1038671-2022-00009
• Device Sequence Number: 17298128
• Product Code: JWH
• UDI-Device Identifier: 10885862048318
• UDI-Public: 10885862048318
• 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: 2016
• Device Explanted Year: 2020
• 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: 07/08/2019
• Device Model Number: PS TIBIAL INSERTS SZ 3, 11MM
• Device Catalogue Number: 204-23-11
• 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: 07/11/2011
• 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: Unknown