MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR RAZ STEM SZ 4; HIP COMPONENT

Model Number PYRD0004

Device Problem Failure to Osseointegrate (1863)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, cup appears to be incorrectly positioned.Head was removed along with shell and came out with the neck extraction device.Appears that there was a little ingrowth on the cup and stem.(right hip).Photos of explants and x ray are being sent.

• Brand Name: PROFEMUR RAZ STEM SZ 4
• 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: 10828992
• MDR Text Key: 215912254
• Report Number: 3010536692-2020-00696
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PYRD00041
• UDI-Public: M684PYRD00041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

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: Health Professional
• Device Model Number: PYRD0004
• Device Catalogue Number: PYRD0004
• Device Lot Number: 047426333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/12/2020
• 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