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

Model Number	101-1307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6b date of explant - at the time of the report, an explant was planned but had not occurred yet.
Event or Problem Description
A total hip arthroplasty was performed on (b)(6) 2023 and an exam performed one week later showed no abnormality.After the patient complained of pain, a ct on (b)(6) 2023 revealed a bone fracture.A revision was planned to replace the hip stem but had not taken place at the time of this report and no further information has been provided by the hospital.This report is being submitted because a proposed intervention was mentioned.

• Brand Name: OVATION TRIBUTE
• Common Device Name: HIP STEM PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 19012668
• Report Number: 1722511-2024-00005
• Device Sequence Number: 7981574
• Product Code: LPH
• UDI-Device Identifier: 00822409011285
• UDI-Public: (01)00822409011285(17)280926(10)A293706
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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 Model Number: 101-1307
• Device Lot Number: A293706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown