MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) A-CLASS(R) FEMORAL COMPONENT; HIP COMPONENT

Catalog Number 38PF-1056

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/07/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised due to mom complications (right).

Manufacturer Narrative

Investigation is not complete; this report will be updated upon investigation completion.Trends will be evaluated.

• Brand Name: CONSERVE(R) A-CLASS(R) 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 ; 901867-441
• MDR Report Key: 4080609
• MDR Text Key: 12715602
• Report Number: 3010536692-2014-01336
• 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,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38PF-1056
• Device Lot Number: 109854129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/07/2012
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2015
• 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: 63 YR