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

Catalog Number 3802-0052

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Toxicity (2333); Test Result (2695); No Information (3190)

Event Date 12/15/2005

Event Type  Injury  

Event Description

Allegedly the patient was revised due to the following mom complications: failed left total hip arthroplasty; pain (left).

Manufacturer Narrative

Additional information received from litigation: updated incident description and event problem and evaluation codes.

Event Description

Allegedly the patient was revised due to unknown reasons.

• Brand Name: CONSERVE(R) FEMORAL RESURFACING 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 ; 9018674410
• MDR Report Key: 4271280
• MDR Text Key: 5296347
• Report Number: 3010536692-2014-01695
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3802-0052
• Device Lot Number: 04480393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2005
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2014
• 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