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

Catalog Number 38HM-1052

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/04/2014

Event Type  Injury  

Event Description

Allegedly, patient revised due to shedding of metal debris into the bloodstream; tissue damage; persistent paint and decreased mobility.Mom complications (right).

Manufacturer Narrative

This is the same event as 3010536692-2015-00061.

• Brand Name: CONSERVE(R) SF CEMENTED FEMORAL COMPONENT
• Type of Device: HIP JOINT 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: 4405488
• MDR Text Key: 15821308
• Report Number: 3010536692-2015-00060
• 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: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 38HM-1052
• Device Lot Number: 0401110701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/04/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/17/2014
• 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: 48 YR