MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) female patient, weight (b)(6)., approximately five years post initial right side tka, patient had a revision of the femoral and tibial components, lateral retinacular release, and lateral patella facetectomy.
Additional Manufacturer Narrative
Concomitant medical products: optetrak hi-flex tibial insert sz 3 15mm (cat# 244-23-15 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, this 64 y/o female patient, weight 285 lbs., approximately five years post initial right side tka, patient had a revision of the femoral and tibial components, lateral retinacular release, and lateral patella facetectomy.No additional information after 3 attempts.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: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT
• 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; exactech, inc.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13624648
• Report Number: 1038671-2022-00229
• Device Sequence Number: 5059847
• Product Code: JWH
• UDI-Device Identifier: 10885862063847
• UDI-Public: 10885862063847
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: OPTETRAK ASY HI-FLEX PS CEM FEM, SZ 3, RIGHT
• Device Catalogue Number: 244-03-03
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: - CEMENTED FINNED TIB. TRA SZ 3F/4T; - THREE PEG PATELLA 41MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 129 KG