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

Model Number PHAC1254

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, sudden fracture of a hip endoprosthesis shaft in the cone area.It is an implant with a modular neck part that is broken.The damaged tapered implant could not be removed from the stem implant, so the femoral stem component had to be completely changed.(b)(4).

Manufacturer Narrative

Included remedial action related to catalog number phac1254.

Manufacturer Narrative

Included implantation year and updated medical device problem codes.

• 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
• MDR Report Key: 11568026
• MDR Text Key: 242196309
• Report Number: 3010536692-2021-00175
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (y/n): N
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

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: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 1521980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 03/04/2021; 03/04/2021
• Supplement Dates FDA Received: 05/25/2021; 06/01/2021
• Removal/Correction Number: Z-2743-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR