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

Catalog Number PHA0-1232

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Allegedly the patient was revised due to dislocation subluxation (left).Revision njr index no: (b)(4).Additional product information received on 1/12/2017: neck product information now available.

• 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 ; 9018674771
• MDR Report Key: 6280697
• MDR Text Key: 65854646
• Report Number: 3010536692-2017-00081
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K003016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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: 1490000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/12/2017
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention