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

Model Number PHA0-1204

Device Problems Break (1069); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

Allegedly, patient is suffering from possible modular neck fracture.

Manufacturer Narrative

Additional information received from litigation: updated part number, implant and explant dates.

Manufacturer Narrative

After the initial report it was determined that the implant and explants dates were reported swapped.We have corrected the report.

Manufacturer Narrative

Additional information received from litigation: updated part and lot number.

• 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: 5336435
• MDR Text Key: 34737752
• Report Number: 3010536692-2015-02093
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/30/2015

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
• Device Operator: Other
• Device Model Number: PHA0-1204
• Device Catalogue Number: PHA0-1204
• Device Lot Number: 127519787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: 12/17/2015; 12/17/2015; 12/17/2015
• Supplement Dates FDA Received: 05/25/2018; 06/18/2018; 09/17/2018
• 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