MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) RAZ STEM; HIP COMPONENT

Model Number	PYRD-0004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, pain in the lateral proximal femur, stem came out with the neck and head.Stryker stem and head went in and none of our implant went it.Additional information on 08/29/2019: component not revised: metal liner 44mm dynasty part number : dlco-6644 lot number: 010138421.Cocr femoral head 28mm slt taper +10.5mm neck confirmed as revised.

• Brand Name: PROFEMUR(R) RAZ STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9779364
• Report Number: 3010536692-2020-00176
• Device Sequence Number: 11425440
• Product Code: LPH
• UDI-Device Identifier: M684PYRD00041
• UDI-Public: M684PYRD00041
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: PYRD-0004
• Device Catalogue Number: PYRD-0004
• Device Lot Number: 010969362
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR