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

Model Number PHAC1254

Device Problem Material Disintegration (1177)

Patient Problems Autoimmune Reaction (1733); Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient will be revised due to allergic reaction to cobalt chromium metal ions and particulate debris.

Manufacturer Narrative

Additional information received on 03/18/1010: mpo was informed that the revision surgery was canceled.

Event Description

Allegedly, patient will be revised due to allergic reaction to cobalt chromium metal ions and particulate debris.Additional information received on 03/18/2020: mpo was informed that the revision surgery was canceled.Additional information received on 12/22/2020 from legal department ((b)(6)): original and revision surgery dates, reason of incident, products involved in the case.Allegedly, the patient underwent into revision surgery due to metallosis throughout the joint with black staining tissue and necrotic debris.Black corrosive product noted at the head, neck, and neck stem modular junctions.

Manufacturer Narrative

Additional information received on 12/22/2020 from wright legal department ((b)(6)): update implant and explant surgery dates, reason description, patient information, products involved in the case (product id and lot information) and updated investigation.

• 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: 9913781
• MDR Text Key: 186560873
• Report Number: 3010536692-2020-00311
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2021

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: 08985005601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 03/10/2020
• Supplement Dates FDA Received: 06/11/2020; 01/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention