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	No Code Available (3191)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No radiographs were provided.The patient's bone quality is unknown.Parts met acceptance criteria upon release.There is no evidence of implant or instrumentation malfunction.The instructions for use list femoral bone fracture during intra-operative bone preparation or impaction as a potential adverse effect.
Event or Problem Description
An intraoperative fracture occurred during placement of a hip stem.The surgeon reported a crack might have been caused by rasping too hard.When the implant was inserted, the crack might have caused a diagonal fracture around the lesser trochanter.The surgeon provided additional support with a plate and cable around the fracture line followed by cement around the stem.

• 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: 7372185
• Report Number: 1722511-2018-00006
• Device Sequence Number: 10772553
• Product Code: LPH
• UDI-Device Identifier: 00822409011018
• UDI-Public: (01)00822409011018(17)211212(10)A172028
• 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): 03/26/2018

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: 12/12/2021
• Device Model Number: 101-0308
• Device Lot Number: A172028
• 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: 03/12/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1