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

Catalog Number 2601-0007

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Failure to Align (2522)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/10/2013

Event Type  Injury  

Event Description

Allegedly the patient was revised due to aseptic loosening stem; dissociation of liner; implant fracture head; implant fracture stem; malalignment stem; periprosthetic fracture stem (left).Secondary revision njr index no: (b)(4).

Manufacturer Narrative

This is the same event as 3010536692-2015-00351, -00353.This report will be updated when investigation is complete.Trends will be evaluated.This event occurred in the (b)(6).

Manufacturer Narrative

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

• 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: 4508439
• MDR Text Key: 5443628
• Report Number: 3010536692-2015-00352
• Device Sequence Number: 1
• Product Code: LPH
• 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: 2601-0007
• Device Lot Number: 098611681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/10/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 02/11/2015
• 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