MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01232

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/07/2011

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluate.

Event Description

Allegedly, left hip endoprosthesis dislocation due to extensive internal rotation of the hip joint, closed reduction and immobilisation resolved the problem, no further instability of the enrolled hip.

Manufacturer Narrative

Updated intial reporter information.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9953578
• MDR Text Key: 187406914
• Report Number: 3010536692-2020-00335
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012321
• UDI-Public: M684PHA012321
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01232
• Device Catalogue Number: PHA01232
• Device Lot Number: 1101255908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2020
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention