MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR COCR NECK; HIP COMPONENT

Model Number PHAC-1202

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient having pain beginning approximately 4 months post op and increasing over time.No evidence of osteolysis, loosening or pseudotumor.Arthrocentesis showed no infection but fluid described as dark or cloudy.This could indicate metallosis but there was no follow-up.

• Brand Name: PROFEMUR COCR NECK
• 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: 11050480
• MDR Text Key: 223171596
• Report Number: 3010536692-2020-00781
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC-1202
• Device Catalogue Number: PHAC-1202
• Device Lot Number: 0111184613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 61