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

Model Number	101-0304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a bhp operation and after inserting the stem, a fracture was observed on x-ray.The surgeon wrapped cable around the fracture and closed.The doctor commented that it was a technical issue and not related to the product.

• 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: 8125186
• Report Number: 1722511-2018-00037
• Device Sequence Number: 1616176
• Product Code: LPH
• UDI-Device Identifier: 00822409010974
• UDI-Public: (01)00822409010974(17)210125(10)A159927
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: 01/25/2021
• Device Model Number: 101-0304
• Device Lot Number: A159927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/03/2018
• 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