MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK VAR/VAL 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1254

Device Problem Mechanical Problem (1384)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, the neck sleeve and head came out as one during explant surgery and neck trunnion was black.Left hip.Head and necks were replaced.Components not revised: conserve® plus cup product number 38024450 lot number 029783710.Profemur® plasma z stem product number pha00262 lot number 049943762.Drive shaft cannula product number 2007st20 lot number 128733794.

• Brand Name: PROFEMUR NECK VAR/VAL 8DG LONG COBALT CHROME
• 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: 10816430
• MDR Text Key: 215519311
• Report Number: 3010536692-2020-00693
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 08985005601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2020
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-2588-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention