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

Model Number PHA0E244

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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
• 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: 10944176
• MDR Text Key: 219497761
• Report Number: 3010536692-2020-00729
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PHA0E2441
• UDI-Public: M684PHA0E2441
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: PHA0E244
• Device Catalogue Number: PHA0E244
• Device Lot Number: 1561007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/11/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 01/26/2021
• 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
• Patient Age: 70 YR
• Patient Weight: 94