MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA012X4

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 10/17/2019

Event Type  Injury  

Event Description

Revision was for a broken neck.Could not get the broken neck out.They believe the implants are a 15 mm lx stem, 52 mm med conserve head, long varus titanium neck, 58mm conserve plus shell.22-oct-19 contacted reporter ((b)(6)).Allegedly, none of the implants were replaced.She asked for additional feedback from (b)(6).07-nov-19 (b)(6) (distributor) stated via email: "the stem, neck and head were removed.The cup/shell was left.Patient received a revision stem and head and the acetabular side was converted to a dual mobility.".

• Brand Name: PROFEMUR® MODULAR FEMORAL 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: 9694472
• MDR Text Key: 182360881
• Report Number: 3010536692-2020-00106
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA012X4
• Device Catalogue Number: PHA012X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2019
• Date Manufacturer Received: 10/17/2019
• 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: 60 YR