MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® ROUGHENED DISTAL STEM, TAPERED; HIP COMPONENT

Model Number PPW38024

Device Problems Break (1069); Corroded (1131); Difficult to Remove (1528)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 12/08/2020

Event Type  Injury  

Event Description

Allegedly, on (b)(6) 2010, patient had a wright medical profemur r bowed distal stem and proximal body, mated with a profemur plus cocr modular neck, implanted in his left hip.On (b)(6) 2020, patient's profemur r bowed distal stem suddenly and without warning failed, fracturing in two near the top of the stem, below the morse taper.On (b)(6) 2020, patient had a revision surgery performed on his left.In the course of the (b)(6) 2020, revision surgery the doctor noted that the proximal body and head were grossly loose and were extracted by hand.Surgeon performed an extended trochanteric osteotomy to remove the distal remnant of the fractured profemur r bowed distal stem.In the (b)(6) 2020, revision surgery the wright medical profemur r bowed distal stem, profemur proximal body, profemur plus cocr modular neck, and ceramic femoral head were removed from the body of the patient, and replaced with stryker artificial devices, including a stryker restoration modular size 15 195mm curved stem, 25mm +0 proximal body and a 32mm +4 delta ceramic head.In the course of the (b)(6) 2020, revision surgery doctor found the acetabular component (the cup) to be well fixed with a ceramic liner and left those components in place.Because of the extended trochanteric osteotomy, and an intraoperative fracture, multiple cables were needed to securely fix the bone at the osteotomy site.Patient still experiences residual symptoms following the (b)(6) 2020, left hip revision surgery.Post-revision examination of the explanted profemur plus cocr modular neck at the junction with profemur proximal body reveals that those devices had corroded at the neck stem junction.However, even though patient's left hip devices were in substantially the same condition in all relevant respects as when they left wright medical's control, due to corrosion at the neck-stem junction, and continuing osteolysis of the stem in the femur, the need for revision in the foreseeable future was probable.It is indicated that patient's profemur plus cocr modular neck suffered from micromotion, fretting corrosion, galvanic corrosion, and fracture.Due to micromotion and fretting corrosion of the oblong taper of the profemur plus cocr modular neck where it seated in the pocket of the stem, the profemur plus cocr modular neck implanted in patient's left hip corroded, causing osteolysis of the proximal hip stem, leading to the fracture of the hip stem, and injury to patient.As a direct and proximate result of the failure of the profemur plus cocr modular neck and profemur r hip system patient has sustained injuries and damages including, but not limited to: serious and permanent physical injuries to bone, muscle, tendons, tissues and nerves in his hip and pelvis; past and future pain, suffering, and anguish, both in mind and in body; physical disability, past and future; physical impairment; disfigurement and loss of enjoyment of life.Patient has had another adverse event happened on 2010.This event has been captured under microport orthopedics group number: (b)(6).

Manufacturer Narrative

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

• Brand Name: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED
• 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: 16108265
• MDR Text Key: 306786318
• Report Number: 3010536692-2023-00003
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PPW380241
• UDI-Public: M684PPW380241
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPW38024
• Device Catalogue Number: PPW38024
• Device Lot Number: 0301072894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2022
• Date Manufacturer Received: 12/06/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 117 KG