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

Model Number PHAC1252

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, components revised for unknown reasons.High bmi.

Event Description

Allegedly, components revised for unknown reasons.Patient number: (b)(6).Additional information received on april 11,2022: allegedly, patient presented with pain and lack of mobility.The right-sided device failed due to corrosion at the neck stem junction.On or about (b)(6) 2022, it was discovered that the right-sided device failed due to corrosion of the oblong taper of the profemur cocr modular neck where it seated in the pocket of the profemur titanium stem, which caused physical injury to patient.

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG SHORT 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: 13397051
• MDR Text Key: 284801457
• Report Number: 3010536692-2022-00026
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1525759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2022
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female