MAUDE Adverse Event Report: STRYKER/HOWMEDICA OSTEONICS CORP STRYKER METAL-ON-METAL HIP IMPLANT; PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Thrombus (2101); Tissue Damage (2104)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Dr.(b)(6) replaced ball and socket components, originally placed in (b)(6) 2008.Right hip.Dr.(b)(6) stated that the sciatic nerve had been traumatized during the extended procedure to clear the damaged tissue and took over two hours longer.The right foot did not respond to physical therapy in the hospital, so i was released with an afo brace.Further testing and continued disability caused the dr.To reattack the damaged right hip from the rear on (b)(6) 2019.During this procedure scar tissue was removed from the sheath on the nerve manually through the 8 inch incision.Electric stimulation of the nerve caused toes to move.Still treatment for lower extremity blood clots and foot swelling continue into the sixth month, with minor improvement.

Event Description

Add'l info received on 03/23/2020 from reporter for report mw5093848.Gentlemen: the items are my wife's request for a class 1 recall of stryker metal-on-metal hip head ball components.Included are her personal notes, dr (b)(6) surgical reports (3), dr.(b)(6) pre-surgical comment, lab reports from (b)(6) 2019 - (b)(6)2019, and her fda form 3500 submission.The fda was being asked to start the recall class 1, for the sake of other patients who might have the same corrosion caused metallosis.A report on (b)(6) and a market publication of november 2014 show that over a billion dollars in federal court ((b)(6)) have been paid by stryker for similar hip components, yet our doctor has not been notified of the recall.To date, (b)(6), has been unable to use her right foot.After the (b)(6) surgeries, with charges submitted to (b)(6) and (b)(6) - for- life, the government asked the cause.We responded that it was metal corrosion from a stryker hip replacement of (b)(6) 2008.We were instructed to wait upon the u.S.Treasury being made whole, before submitting our claim.Now, approaching nine months, requiring 24/7 care, we have asked the fda for the recall.Expecting that stryker would respond quickly to the government, we borrowed against our personal retirement accounts, for a used vehicle, and other disability support items.Fast forward into 2020, no response from our (b)(6) attorney cause us to make the following: declare the class 1 recall; settle the current u.S.Government claims, and future claims related to it; consider how stryker corporation might replace our common stock losses from our retirement accounts.(this is not a litigation, because we are directed to await the government).(coronavirus market affects all of us with our holdings).

• Brand Name: STRYKER METAL-ON-METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-FEMORAL, METAL
• Manufacturer (Section D): STRYKER/HOWMEDICA OSTEONICS CORP
• MDR Report Key: 9859692
• MDR Text Key: 184479789
• Report Number: MW5093848
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 79 YR
• Patient Weight: 76