MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOWN CANCELLOUS SELF-TAPPING BONE SCREW; KNEE COMPONENT

Model Number 1808030X

Device Problems Break (1069); Loss of Osseointegration (2408)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, wright medical mom total hip replacement device failure.Loosening and deterioration of metal component.Metal ions broke screw off inside of patient causing a hip dislocation.Patient required immediate hip revision surgery to replace cup.Patient has metallosis damage both before and after device failure.Patient was never notified of recall or problems with wright medical devices.Patient complained for several years of pain, stiffness, sciatic, cervical nerve pain, went to pain clinic multiple times for injections for pain.Patient had nerve conduction tests, mri's.Other severe health problems with kidney, thyroid, female reproductive issues (removal of ovary) same side of metal-on-metal hip replacement.Blood tests of cobalt and chromium are still high after hip replacement.No accountability of wright medical for promoting device that injured people.No notice to patient of recall or "fraudulent fda approval of device".Now patient is informed of a 10-year statute of limitation on medical devices even though patient has complained of problems, pain, health issues including having x-rays, mri's.No one informed patients that metallosis cannot be seen on mri's or x-ray.Hip replacement was performed on 2008.Hip revision surgery of cup, screw was completed on 2021.Patient still have the wright medical stem but it has not been indicated if the head and neck have been revised.No parts id or lot numbers have been provided for any of the components involved in this event.Email notification of this complaint was received from stryker trauma & extremities complaints but the complaint itself comes from fda medwatch program.Mdr report #: mw5111244.

Manufacturer Narrative

Section f.6: awareness date updated.

• Brand Name: UNKNOWN CANCELLOUS SELF-TAPPING BONE SCREW
• Type of Device: KNEE 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: 15469355
• MDR Text Key: 300431389
• Report Number: 3010536692-2022-00343
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1808030X
• Device Catalogue Number: 1808030X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2022
• Date Manufacturer Received: 08/24/2022
• 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