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

Catalog Number PHA0-1232

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to pain; popping clicking; metallosis- right.

Manufacturer Narrative

This is the same event as 3010536692-2015-00736, -00737, -00738.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• 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: 4736905
• MDR Text Key: 18039209
• Report Number: 3010536692-2015-00739
• Device Sequence Number: 1
• Product Code: LWJ
• 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
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PHA0-1232
• Device Lot Number: 048587947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/13/2013
• Event Location: Hospital
• Date Manufacturer Received: 04/08/2015
• 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 Weight: 108