MAUDE Adverse Event Report: STRYKER TRAUMA GMBH STRYKER ALL-INCLUSIVE LEFT HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Device Problems Break (1069); Nonstandard Device (1420); Material Separation (1562)

Patient Problems Flashers (1864); Headache (1880); Loss of Vision (2139); Confusion/ Disorientation (2553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2021

Event Type  Injury  

Event Description

I have a revised metal-on-metal hip replacement both my hips, the ones that were recalled for the same model numbers as the ones that were implanted in me with the exception of an added liner.It separated the metal from metal that part broke the liner cup and for some time i had metal on metal grinding, really bad headaches that got worse over time.I didn't notice those side effects, those have occurred almost a year prior.I have peripheral vision loss with bright lights in my peripheral, flashes, confusion.I wake up in the morning and everything in my house seems to my memory to be just the opposite of where it's located.Now since the tv to couch and all that so bad as to where i'm so confused, i can't quit crying until out and leave it goes away after having this revision surgery of course.I did my research and i found all my symptoms are metal on metal poisoning, metallosis which was noted in my surgeons after surgery report.Right before surgery the anesthesiologist inserted a nerve blocker into my left thigh; when she pulled the needle from my thigh black metallosis liquid came out of my leg, everyone in the room to the oh my god what is that black stuff.Then i was asleep i look at the reports from the anesthesiologist, and my doctor there is no mention of the anesthesiologist ever finding any black liquid in my leg.The only one mention anything about metallosis with the doctor after my surgery he knew about that before my surgery that should have been precautions taken, i may lose my eyesight, my ability to walk and everything.Please help me with this.(b)(6).I have no idea what my test results i need to have but they're all on my online medical chart, and i can have access give it to you through that i would never ask if i wanted to send it back to the fda.All of the times on any notes and preop reports on my medical reports right before i was put under in, the blacklist was found in my leg from the anesthesiologist.I had just text my wife and hit send and it takes her and let her know and next thing i know i was asleep, so i have records of electronic phone records at the time that i found out about the black liquid because the doctor didn't say anything about the black liquid until after the surgery and stated that he found it as he opened my leg that's not true that's a blatant lie my phone records will prove it please help me.I don't want to be blind, and i don't want to be crippled.I just had a son he's only (b)(6) months old.Fda safety report id# (b)(4).

• Brand Name: STRYKER ALL-INCLUSIVE LEFT HIP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER TRAUMA GMBH
• MDR Report Key: 12547342
• MDR Text Key: 274078247
• Report Number: MW5104269
• Device Sequence Number: 1
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 43 YR
• Patient Weight: 104