MAUDE Adverse Event Report: ORTHO DEVELOPMENT LEGEND; HIP PROSTHESIS

Model Number	170-0456
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent total hip arthroplasty on (b)(6) 2019.On (b)(6) 2019, the surgeon performed a revision because the acetabular cup had changed position.No patient trauma was reported.

• Brand Name: LEGEND
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8532052
• Report Number: 1722511-2019-00005
• Device Sequence Number: 13849654
• Product Code: LPH
• UDI-Device Identifier: 00822409035311
• UDI-Public: (01)00822409035311(17)230816(10)A200147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161080
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: 08/16/2023
• Device Model Number: 170-0456
• Device Lot Number: A200147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR