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

Model Number	PHA0E244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, the classic stem fractured post-operatively.Additional information received on 11/03/2020 from (b)(6): adding a new incident for delta ceramic head and its partial product information.Acetabular shell and liner are not mpo products.Additional information received on 11/11/2020 from (b)(6): adding patient personal information, reason for revision details, revision facility, implant and explant date.Stem broke while patient was walking upstairs.

• Brand Name: PROFEMUR CLASSIC STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10944176
• Report Number: 3010536692-2020-00729
• Device Sequence Number: 18993130
• Product Code: LPH
• UDI-Device Identifier: M684PHA0E2441
• UDI-Public: M684PHA0E2441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: Other
• Device Model Number: PHA0E244
• Device Catalogue Number: PHA0E244
• Device Lot Number: 1561007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/11/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 94