MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately three years post tka, the (b)(6) female patient experienced pain and functional limitation of the left knee with inflammatory changes in surgical wound, radiography evidence loosening of tibial and femoral component, orders are given in first time with spacer and culture taking.There is no further information found regarding treatment or a revision.The event is possibly related to the device and to the procedure.
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 204-23-11), tibial tray (cat# 200-04-32), patella (cat# 200-02-29).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, h1, h2, h3 and h6 have been updated accordingly.As reported by the exactech knee replacement study, approximately three years post tka, the 71 years old female patient experienced pain and functional limitation of the left knee with inflammatory changes in surgical wound, radiography evidence loosening of tibial and femoral component, orders are given in first time with spacer and culture taking.There is no further information found regarding treatment or a revision.The event is possibly related to the device and to the procedure.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient conditions, which caused the infection and therefore, causing the tibial and femoral loosening.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,
• 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: 13081981
• Report Number: 1038671-2021-00736
• Device Sequence Number: 4517432
• Product Code: JWH
• UDI-Device Identifier: 10885862063199
• UDI-Public: 10885862063199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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 Model Number: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,
• Device Catalogue Number: 234-02-03
• 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: 12/04/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 97 KG