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

Model Number PHA00234

Device Problems Corroded (1131); Material Disintegration (1177)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient presented elevated cobalt ion levels and pain.The device failed due to corrosion at the neck-stem junction of the device, corrosion on the oblong taper where the neck was seated in the pocket of the profemur titanium stem, which caused adductor damage, soft tissue reaction and pseudotumor reaction.During the revision the surgeon removed the failed components of the profemur total hip system.

Manufacturer Narrative

Updated patient information and event codes.This event is related to reports 3010536692-2019-00438, 3010536692-2019-00439 and 3010536692-2019-00440.

Manufacturer Narrative

Corrected patient and device codes.

• Brand Name: PROFEMUR® Z STEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9733090
• MDR Text Key: 180756680
• Report Number: 3010536692-2020-00144
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PHA002341
• UDI-Public: M684PHA002341
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA00234
• Device Catalogue Number: PHA00234
• Device Lot Number: 0411347675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2020
• Date Manufacturer Received: 01/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention