MAUDE Adverse Event Report: ORTHO DEVELOPMENT OVATION TRIBUTE; HIP PROSTHESIS

Model Number	101-0308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent total hip arthroplasty on (b)(6) 2018.During rehabilitation, a femoral fracture occurred and on (b)(6) 2018, the patient was revised and the stem replaced.The surgeon indicated that the fracture occurred because the patient applied a stronger force than usual during rehabilitation.This report was the result of a post market survey so the event occurred in 2018 but wasn't reported until 2019.

• Brand Name: OVATION TRIBUTE
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8609862
• Report Number: 1722511-2019-00013
• Device Sequence Number: 2180066
• Product Code: LPH
• UDI-Device Identifier: 00822409011018
• UDI-Public: (01)00822409011018(17)220602(10)A179019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133386
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 06/02/2022
• Device Model Number: 101-0308
• Device Lot Number: A179019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR