MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY(R) PC SHELL; HIP COMPONENT

Catalog Number DSPC-GD52

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 01/20/2015

Event Type  Injury  

Event Description

Allegedly, patient revised due to persistent hip pain, elevated cobalt chrome levels, impaired gait and metallosis with loosening of acetabular component (right).

Manufacturer Narrative

This is the same event as 3010536692-2015-00524, -00526.

• Brand Name: DYNASTY(R) PC SHELL
• 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 ; 901867-441
• MDR Report Key: 4600866
• MDR Text Key: 20752541
• Report Number: 3010536692-2015-00525
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

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
• Device Operator: Physician
• Device Catalogue Number: DSPC-GD52
• Device Lot Number: 078664452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/20/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/13/2015
• 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: 60 YR