MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS BIPOLAR HEMIARTHROPLASTY; BIPOLAR HIP IMPLANT

Model Number GLBP-3654

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

The patient was recovering very uneventfully and very quickly.Status: post right hip hemiarthroplasty for femoral neck fracture on (b)(6) 2018; and last week apparently fell and sustained a posterior dislocation of the right total hip with a dissociation of the bipolar component.Microport orthopedic: (b)(6) 2018.

• Brand Name: BIPOLAR HEMIARTHROPLASTY
• Type of Device: BIPOLAR HIP IMPLANT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS; arlington TN 38002
• MDR Report Key: 7769072
• MDR Text Key: 116785711
• Report Number: MW5078986
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLBP-3654
• Device Catalogue Number: 26000026
• Device Lot Number: 102489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 61