MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) SF CEMENTED FEMORAL COMPONENT; HIP COMPONENT

Catalog Number 38HM-1038

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

This is the same event as 3010536692-2016-00249.

Event Description

Allegedly the patient was revised due to the following mom complications: shedding of metal debris into the bloodstream; tissue damage; persistent pain and decreased mobility (right).

• Brand Name: CONSERVE(R) SF CEMENTED FEMORAL COMPONENT
• 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 ; 9018674771
• MDR Report Key: 5420076
• MDR Text Key: 37801108
• Report Number: 3010536692-2016-00250
• Device Sequence Number: 1
• Product Code: KXA
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 38HM-1038
• Device Lot Number: 025174262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR