MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for STRYKER METAL-ON-METAL HIP IMPLANT manufactured by Stryker/howmedica Osteonics Corp.
[184479789]
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.
Patient Sequence No: 1, Text Type: D, B5
[185002394]
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 webmd/tv 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 effects all of us with our holdings).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093848 |
| MDR Report Key | 9859692 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-07-01 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER METAL-ON-METAL HIP IMPLANT |
| Generic Name | PROSTHESIS, HIP, HEMI-FEMORAL, METAL |
| Product Code | KWL |
| Date Received | 2020-03-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER/HOWMEDICA OSTEONICS CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-03-19 |