MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. WMT SLT TAPER COBALT-CHROME FEMORAL HEAD; HIP COMPONENT

Catalog Number 2601-0008

Device Problem Failure to Align (2522)

Patient Problem Pain (1994)

Event Date 11/20/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised due to malalignment socket; pain (left).Revision njr index no: (b)(4).

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This event occurred in (b)(6).

• Brand Name: WMT SLT TAPER COBALT-CHROME FEMORAL HEAD
• 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: 4494695
• MDR Text Key: 13194592
• Report Number: 3010536692-2015-00332
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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: Other
• Device Catalogue Number: 2601-0008
• Device Lot Number: 0211280941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/20/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• 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