MAUDE Adverse Event Report: ORTHO DEVELOPMENT E-VITALIZE; TOTAL KNEE PROSTHESIS

Model Number	166-5518
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the patient received total knee arthroplasty.Subsequently, the patient reported pain.An x-ray confirmed that the tibial insert had migrated from its original position.On (b)(6) 2019, the surgeon revised the knee and replaced the 18mm insert with a 20mm insert.
Additional Manufacturer Narrative
Failure most likely due to posterior locking tabs not being engaged fully upon implantation.

• Brand Name: E-VITALIZE
• Common Device Name: TOTAL KNEE PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8588975
• Report Number: 1722511-2019-00009
• Device Sequence Number: 19406574
• Product Code: JWH
• UDI-Device Identifier: 00822409007318
• UDI-Public: (01)00822409007318(17)230815(10)A168165
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 08/15/2023
• Device Model Number: 166-5518
• Device Lot Number: A168165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1