MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. WRIGHT HIP; HIP COMPONENT

Device Problem Device Slipped (1584)

Patient Problem Discomfort (2330)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Allegedly, patient revised due to loosening of acetabular component and discomfort.

Manufacturer Narrative

Investigation has not been completed.Trends will be evaluated.

• Brand Name: WRIGHT HIP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 901867-477
• MDR Report Key: 4892937
• MDR Text Key: 6019856
• Report Number: 3010536692-2015-01386
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/19/2015
• Event Location: Hospital
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR