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

Model Number	101-0307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a patient received total hip arthroplasty.On (b)(6) 2020, it was revised and the stem removed due to a bone fracture that had developed.

• 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: 11366615
• Report Number: 1722511-2021-00005
• Device Sequence Number: 19066041
• Product Code: LPH
• UDI-Device Identifier: 00822409011001
• UDI-Public: (01)00822409011001(17)250511(10)A236384
• 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: 2020
• Device Explanted Year: 2020
• 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): 01/27/2021

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: 05/11/2025
• Device Model Number: 101-0307
• Device Lot Number: A236384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1