MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR Z STEM; HIP COMPONENT

Model Number	PHA00244
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening stem.Revision njr number: (b)(4).Side:r.Primary asa: p4 - life threatening disease.Components not revised: procotyl l beaded and ha coated cup size 52mm product id pha06262, lot id 1414732.Rim-lock a-class cross- linked polyethylene liners 15deg 32mm id group e product id pha04660, lot id 1404239.

• Brand Name: PROFEMUR Z STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10337809
• Report Number: 3010536692-2020-00509
• Device Sequence Number: 14219250
• Product Code: LPH
• UDI-Device Identifier: M684PHA002441
• UDI-Public: M684PHA002441
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: PHA00244
• Device Catalogue Number: PHA00244
• Device Lot Number: 601139971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention