MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD; HIP COMPONENT

Catalog Number 2600-0010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Pain (1994); Scar Tissue (2060); Toxicity (2333)

Event Date 01/13/2015

Event Type  Injury  

Event Description

Allegedly, patient was revised due to: excruciating hip pain, elevated blood cobalt; chromium ion levels; metallosis; metallic granulation tissue; scare tissue:- right.

Manufacturer Narrative

This is the same event as 3010536692-2015-01380, -01381.(b)(4).

• Brand Name: LINEAGE(R) TRANSCEND(R) CERAMIC 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: 4884919
• MDR Text Key: 19302348
• Report Number: 3010536692-2015-01382
• Device Sequence Number: 1
• Product Code: MRA
• 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
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 2600-0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/13/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/01/2015
• 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: 72 YR