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

Model Number	101-0306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient presenting with a peri-stem fracture received total hip arthroplasty on (b)(6) 2019 with no fractures confirmed during or immediately after the operation and no problems.On (b)(6) 2019, stem sinking and an oblique fracture were detected.On (b)(6) 2019, a revision surgery was performed and the stem and head were removed.The fracture was reinforced with cable and another company's components were inserted.The patient was reported to have fragile bone quality and rheumatoid arthritis.

• 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: 11114494
• Report Number: 1722511-2021-00001
• Device Sequence Number: 1059894
• Product Code: LPH
• UDI-Device Identifier: 00822409010998
• UDI-Public: (01)00822409010998(17)240809(10)A221294
• 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
• Device Explanted 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: 08/09/2024
• Device Model Number: 101-0306
• Device Lot Number: A221294
• 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: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1