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

Model Number PHAC1252

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent a right total hip arthroplasty, then she developed some symptoms as: fatigue, diminished resilience, hearing loss and new autoimmune problems and allergies and pain.The exams indicated elevated ions, and a brain scan showed abnormal hypo-metabolism involving her brain due to toxic causes.During revision, the modular neck and delta ceramic head were changed, the stem was sound in about 15 degrees of ante-version.There was gross corrosion at stem end of the modular neck and also metal transfer into bore ceramic head.Components not revised: schanz screw self drill bit 4mm sterile product id: 20070057 lot id: 1472026, path® short drive shaft cannula product id: 20070120 lot id: 1462149, profemur® renaissance® stem reduced sz 10 product id: pls0r410 lot id: 1428536, dynasty® pc shell 46mm group b product id: dspcgb46 lot id: 1413279, dynasty® a-class® std poly liner 28mm group b product id: dlxpgb28 lot id: 1459611, cancellous 6.5mm self-tapping bone screw 1.5cm length product id: 18080300 lot id: 1424851.Mdr report number: mw5093329.

Manufacturer Narrative

Updated initial reporter information.

• 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
• MDR Report Key: 9993371
• MDR Text Key: 189869060
• Report Number: 3010536692-2020-00348
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (y/n): N
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1433424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention