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

Model Number	38AM-4835
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	02/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the same event as 3010536692-2016-00378.See attached.
Event or Problem Description
Allegedly, patient was revised for mom complications: pain; metal wear debris (left).

• Brand Name: CONSERVE(R) TOTAL A-CLASS 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: 5493335
• Report Number: 3010536692-2016-00379
• Device Sequence Number: 2789062
• Product Code: JDL
• UDI-Device Identifier: M68438AM48351
• UDI-Public: M68438AM48351
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2016

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: 38AM-4835
• Device Catalogue Number: 38AM-4835
• Device Lot Number: 087451673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2016
• Initial Date Received by Manufacturer: 02/16/2016
• Supplement Date Received by Manufacturer: 02/16/2016
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 03/10/2016
• 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 Sex: Female