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

Model Number PHAC1232

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Investigation completed.Evaluation codes added.

Event Description

Allegedly, patient was revised due to cocr corrosion at the neck-stem junction of his right hip.

• Brand Name: PROFEMUR NECK A/R 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: 10200298
• MDR Text Key: 200063466
• Report Number: 3010536692-2020-00430
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12321
• UDI-Public: M684PHAC12321
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2020

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: Health Professional
• Device Model Number: PHAC1232
• Device Catalogue Number: PHAC1232
• Device Lot Number: 0801196500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2020
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• 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): Other; Required Intervention