MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

Model Number 510-0214

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 01/30/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 336850990
• Report Number: 1722511-2024-00004
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00822409035991
• UDI-Public: (01)00822409035991(17)280314(10)A284087
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 510-0214
• Device Lot Number: A284087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female