MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

Model Number	510-0214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, an x-ray showed the stem perforating the patient's femur and a crack occurred.The stem was removed, the broaching was redone, and the fracture was wired.The patient's fragile bone quality was referenced as a contributing factor.

• 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: 18832220
• Report Number: 1722511-2024-00004
• Device Sequence Number: 16896288
• Product Code: MEH
• UDI-Device Identifier: 00822409035991
• UDI-Public: (01)00822409035991(17)280314(10)A284087
• 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: 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): 02/28/2024

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: 510-0214
• Device Lot Number: A284087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• 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 Age: 70 YR
• Patient Sex: Female