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

Model Number PHA01254

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, on (b)(6), 2007, patient had a wright medical artificial hip implanted in the right side of his body in a procedure known as a total hip arthroplasty (tha).On (b)(6), 2021, patient's profemur hip suddenly structurally failed, breaking into two pieces at the oblong taper or distal end of the device, where it seated in the pocket of the profemur stem.The structural failure of the titanium profemur® modular neck component of patient's artificial hip was the result of a fatigue failure of the titanium, caused over time by cyclic loading of the device, until more than 90% of the distal end oblong taper had fractured through its cross section, and the remaining connected metal then suffered a tensile failure, resulting in a complete fracture of the modular neck.Because of the fracture of patient's profemur modular neck it was necessary for him to have emergency surgery performed to remove the failed device.On (b)(6) 2021, orthopedic surgeon, performed upon patient's hip a revision hip surgery, including an extended trochanteric osteotomy.Surgeon's revision surgery included the removal from patient, all of the wright medical components of its right hip.Surgeon's revision surgery included an extended trochanteric osteotomy to remove the otherwise well-fixed profemur renaissance stem, splitting the femur to remove the stem, and wiring the femur back together to hold the bone in place around the stem used in revision.

• 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: 15313118
• MDR Text Key: 298817407
• Report Number: 3010536692-2022-00298
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 017405658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2022
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention