MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) Z STEM PLASMA SPRAYED; HIP COMPONENT

Catalog Number PHA0-0266

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Hematoma (1884); Necrosis (1971); Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Reaction (2414)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Alleged patient revised due to mom complications: left sided hip pain, serum cobalt and chromium ion levels; elevated metal particle disease and a pseudotumor; brownish yellow fluid; black tissue; necrotic and fibrinous tissue; focal giant cell reactions and wear debris; hematoma- left.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01166, -01167, -01169.

Manufacturer Narrative

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

• Brand Name: PROFEMUR(R) Z STEM PLASMA SPRAYED
• 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: 4801822
• MDR Text Key: 5895921
• Report Number: 3010536692-2015-01168
• 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
• 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: Other
• Device Catalogue Number: PHA0-0266
• Device Lot Number: 069867827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/04/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• 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: 84 YR