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

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	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient received total hip arthroplasty.During stem insertion, a fracture occurred.An attempt was made to reinforce the fracture with a cable but the reporter stated it was not possible.The stem was inserted and the operation completed.The surgeon commented that the patient's bone quality was poor and the skin incision was too small potentially causing a technical error.

• Brand Name: OVATION TRIBUTE
• 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: 23871194
• Report Number: 1722511-2025-00027
• Device Sequence Number: 19946194
• Product Code: LPH
• UDI-Device Identifier: 00822409011001
• UDI-Public: (01)00822409011001(17)300301(10)A409495
• 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: 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): 12/22/2025

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: 101-0307
• Device Lot Number: A409495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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 Sex: Male