MAUDE Adverse Event Report: ORTHO DEVELOPMENT OVATION; HIP STEM

Model Number	101-0006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient received total hip arthroplasty.During broaching and removal of the broach, a fracture was discovered in the proximal femur.The fracture was reinforced with a cable.After confirming no stem subsidence, the operation was completed.The surgeon commented that the cortical bone of the proximal femur appeared thin, making it prone to fracture.

• Brand Name: OVATION
• Common Device Name: HIP STEM
• 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: 23610036
• Report Number: 1722511-2025-00024
• Device Sequence Number: 21193328
• Product Code: LPH
• UDI-Device Identifier: 00822409010851
• UDI-Public: (01)00822409010851(17)300528(10)A413708
• 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: 2025
• 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): 11/20/2025

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: 101-0006
• Device Lot Number: A413708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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 Age: 88 YR
• Patient Sex: Female