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

Model Number	166-5509
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device return anticipated but not yet received.
Event or Problem Description
On (b)(6) 2018, a patient received total knee arthroplasty.During follow up, the patient complained of minor discomfort.Upon x-ray examination, the surgeon determined that the insert had migrated.On (b)(6) 2019, the knee was revised and a new insert was placed in the patient.
Additional Manufacturer Narrative
Examination of the insert showed damage to the posterior locking tabs.All of the damage appears to be due to the insert not being locked into the tray from the index surgery.

• 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: 8561217
• Report Number: 1722511-2019-00007
• Device Sequence Number: 1836266
• Product Code: JWH
• UDI-Device Identifier: 00822409007240
• UDI-Public: (01)00822409007240(17)250411(10)A192346
• 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: 2018
• 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): 04/29/2019

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: 04/11/2025
• Device Model Number: 166-5509
• Device Lot Number: A192346
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 04/29/2019
• 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