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

Model Number	166-5307
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record notes no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions nor labeling that may have caused or contributed to this mode of failure.
Event or Problem Description
The index surgery occurred on (b)(6) 2018.The report indicates that the tibial insert was out of position so a revision was performed on (b)(6) 2018 to replace the tibial insert.The surgeon indicated that during the initial surgery, he had difficulty properly fitting the insert into the construct using his mis technique.The surgeon also reported that there was deformation on the tibial insert.The insert was discarded and not returned.

• Brand Name: E-VITALIZE
• Common Device Name: TOTAL KNEE REPLACEMENT PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7638091
• Report Number: 1722511-2018-00024
• Device Sequence Number: 2194568
• Product Code: JWH
• UDI-Device Identifier: 00822409007004
• UDI-Public: (01)00822409007004(17)240710(10)A180653
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2024
• Device Model Number: 166-5307
• Device Lot Number: A180653
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1