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

Model Number	101-1306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a bha procedure, the bone proximal to the anterior femur broke during reduction with the final implant.Cable was used to reinforce the bone.The implant was reinserted and the operation completed safely.The surgeon commented that it was possible the stem was driven deeper than the rasp and the force applied during reduction due to a large 48mm cup was great.The patient was confirmed to have vulnerable bone quality.

• Brand Name: OVATION TRIBUTE
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 11118193
• Report Number: 1722511-2021-00002
• Device Sequence Number: 13718137
• Product Code: LPH
• UDI-Device Identifier: 00822409011278
• UDI-Public: (01)00822409011278(17)240709(10)A219180
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 07/09/2024
• Device Model Number: 101-1306
• Device Lot Number: A219180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1