MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL BCH FEMORAL HEAD; HIP COMPONENT

Catalog Number 38CH-4000

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 12/19/2013

Event Type  Injury  

Event Description

Allegedly patient was revised: alleged metallosis-type fluid; metallosis debris and tissue staining: right.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01215, -01216.

Manufacturer Narrative

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

• Brand Name: CONSERVE(R) TOTAL BCH 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 ; 901867-477
• MDR Report Key: 4803678
• MDR Text Key: 5930137
• Report Number: 3010536692-2015-01214
• Device Sequence Number: 1
• Product Code: LZO
• 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

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38CH-4000
• Device Lot Number: 079830420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/19/2013
• Event Location: Hospital
• Date Manufacturer 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: 4 YR