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

Model Number	38014404
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414)
Date of Event	11/11/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the same event as d3010536692-2016-00453.
Event or Problem Description
Allegedly the patient was revised due to mom complications: elevated cobalt and chromium levels; pain; loss of mobility; wear debris causing cloudy fluid.
Additional Manufacturer Narrative
This is the same event as 3010536692-2016-00453.
Event or Problem Description
Allegedly, the patient was revised due to mom complication: elevated cobalt and chromium levels; pain; loss of mobility; wear debris causing cloudy fluid.

• Brand Name: CONSERVE(R) TOTAL HEAD
• Common Device Name: 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: 5633587
• Report Number: 3010536692-2016-00460
• Device Sequence Number: 2789063
• Product Code: KWA
• UDI-Device Identifier: M684380144041
• UDI-Public: M684380144041
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 38014404
• Device Catalogue Number: 3801-4404
• Device Lot Number: 05340994
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2016
• Initial Date Received by Manufacturer: 04/06/2016
• Supplement Date Received by Manufacturer: 04/06/2016
• Initial Report FDA Received Date: 05/05/2016
• Supplement Report FDA Received Date: 05/05/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female