MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

Model Number	510-0218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient received total hip arthroplasty.During surgery, the femur fractured when the stem was inserted.The cabling was applied to stabilize the bone.

• 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: 25685073
• Report Number: 1722511-2026-00019
• Device Sequence Number: 13175815
• Product Code: MEH
• UDI-Device Identifier: 00822409036035
• UDI-Public: (01)00822409036035(17)300426(10)A411438
• 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: 2026
• 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): 07/01/2026

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: 510-0218
• Device Lot Number: A411438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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: 89 YR
• Patient Sex: Male