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

Model Number	3801-4400
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/24/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Orig.Surg.(b)(6) 2006.Allegedly pt.Has pain.Add'l info rec'd 3-1-2012: on (b)(6) 2011 dr.(b)(6) reviewed pt.'s x-rays and discovered the hips were uncemented and there was a mechanical complication.Bilateral hips.Surgery performed by dr.(b)(6) @ (b)(6).Additional information received 04/08/2016.Allegedly the patient was revised due to the following mom complications: metal hypersensitivity.
Additional Manufacturer Narrative
Updating patient code.

• 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: 5639627
• Report Number: 3010536692-2016-00674
• Device Sequence Number: 16829814
• Product Code: KWA
• UDI-Device Identifier: M684380144001
• UDI-Public: M684380144001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2016

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: 3801-4400
• Device Catalogue Number: 3801-4400
• Device Lot Number: 115287547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2012
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2016
• Initial Date Received by Manufacturer: 04/08/2016
• Supplement Date Received by Manufacturer: 04/08/2016
• Initial Report FDA Received Date: 05/09/2016
• Supplement Report FDA Received Date: 05/09/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female