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

Catalog Number DSPC-GF56

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 12/30/2010

Event Type  Injury  

Event Description

Alleged patient revised due to mom complications: metallosis and pseudotumors which he debrided; pain:- right.

Manufacturer Narrative

This is the same event as 3010536692-2015-01132, -01133.

• 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 ; 901867-477
• MDR Report Key: 4799777
• MDR Text Key: 5917442
• Report Number: 3010536692-2015-01131
• 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: 04/28/2015

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-GF56
• Device Lot Number: 068641436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/30/2010
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/27/2015
• 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: 80 YR