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

Catalog Number DSPC-GB48

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 10/05/2011

Event Type  Injury  

Event Description

Allegedly, patient revised due to recurrent instability.(right).

Manufacturer Narrative

This is the same event as 3010536692-2014-01840, -01841, -01842, -01844, -01845.Report will be updated when investigation is complete.Trends will be evaluated.

Manufacturer Narrative

The complaint database has been reviewed and analysis showed no trend for item/lot.

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

• 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: 4361855
• MDR Text Key: 5290406
• Report Number: 3010536692-2014-01843
• 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,Followup,Followup
• Report Date: 12/01/2014

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: Other
• Device Catalogue Number: DSPC-GB48
• Device Lot Number: 017399463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2011
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2015; 04/28/2015
• 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