MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) STEM; HIP COMPONENT

Model Number PHA0-0XXX

Device Problem Corroded (1131)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the patient was revised due to complications: corrosion at the neck and stem junction; prosthetic has caused alval and metal poisoning.(right).

Manufacturer Narrative

Additional information received from litigation on 6.5.19: the product does not have an alleged deficiency against it.Please void the initial and follow up mdr: 3010536692-2017-01546.

• Brand Name: PROFEMUR(R) 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: 7104980
• MDR Text Key: 94469583
• Report Number: 3010536692-2017-01546
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA0-0XXX
• Device Catalogue Number: PHA0-0XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2017
• Date Manufacturer Received: 11/16/2017
• 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