MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT

Catalog Number PHA0-1202

Device Problems Corroded (1131); Material Fragmentation (1261); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Discomfort (2330); Joint Disorder (2373); Fluid Discharge (2686)

Event Date 09/25/2012

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 pain, discomfort, dysfunction and other symptoms; also diseased joint tissue and fluids as well as fretting and corrosion at junction interface.

Manufacturer Narrative

This is the same event as 3010536692-2014-01542_01, -01563, -01565.This report will be updated once investigation is complete.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• 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: 4233740
• MDR Text Key: 12671678
• Report Number: 3010536692-2014-01564
• Device Sequence Number: 1
• Product Code: LWJ
• 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
• Report Date: 10/02/2014

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: PHA0-1202
• Device Lot Number: 068580750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/25/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2014
• 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: 58 YR