MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1204

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly the patient was revised due to aseptic loosening socket; pain.Microport head, neck and stem were implanted with a competitor's shell and liner.Srnjr number: (b)(6).Side: l.Frasa: p3 incapacitating systematic disease.The following component have no alleged deficiency and were not revised during this surgery: profemur® l hip stem size 2 ha coated pha05504 lot # 1526066 qty.1.

• Brand Name: PROFEMUR® NECK NEUTRAL LONG 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: 8732927
• MDR Text Key: 149137856
• Report Number: 3010536692-2019-00855
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12041
• UDI-Public: M684PHAC12041
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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: PHAC1204
• Device Catalogue Number: PHAC1204
• Device Lot Number: 1522564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 05/13/2020
• 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): Required Intervention
• Patient Age: 62 YR