MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

Model Number	510-1212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient had total hip arthroplasty.A postoperative tibial bone fracture occurred.On (b)(6) 2025, a revision was performed to remove the index components which were replaced with another manufacturer's components.

• Brand Name: ENTRADA
• 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: 23600563
• Report Number: 1722511-2025-00023
• Device Sequence Number: 10380736
• Product Code: MEH
• UDI-Device Identifier: 00822409036233
• UDI-Public: (01)00822409036233(17)300430(10)A412121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/19/2025

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: 510-1212
• Device Lot Number: A412121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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: 83 YR
• Patient Sex: Female