MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA0-1254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	02/24/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the same event as 3010536692-2016-00173 & 3010536692-2016-00174.This report will be updated when investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient is suffering from mom complications.(left).Additional information received 04/08/2016: allegedly the patient was revised due to a neck fracture and mom complications:acetabulum showed signs of anteversion, fluid(left).Updated surgery information (implant/explant/op notes), and product (part number/lot number) information.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• 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: 5826400
• Report Number: 3010536692-2016-00664
• Device Sequence Number: 16841324
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2011
• 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: PHA0-1254
• Device Catalogue Number: PHA0-1254
• Device Lot Number: U0470577
• Was Device Available for Evaluation?: No
• 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: 07/27/2016
• Supplement Report FDA Received Date: 07/27/2016
• 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: 64 YR
• Patient Sex: Male