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

Model Number	PYRD0004
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10828992
• Report Number: 3010536692-2020-00696
• Device Sequence Number: 4089082
• Product Code: LPH
• UDI-Device Identifier: M684PYRD00041
• UDI-Public: M684PYRD00041
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: PYRD0004
• Device Catalogue Number: PYRD0004
• Device Lot Number: 047426333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention