MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

Model Number	510-0213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient received total hip arthroplasty.Postoperative x-rays showed a perforated femur at the distal tip of the stem so the patient was reopened.The stem was realigned and correct placement was confirmed with intraoperative imaging.

• 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: 21106427
• Report Number: 1722511-2025-00001
• Device Sequence Number: 12925835
• Product Code: MEH
• UDI-Device Identifier: 00822409035984
• UDI-Public: (01)00822409035984(17)290826(10)A402211
• 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): 12/24/2024

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: 510-0213
• Device Lot Number: A402211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Unknown