MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LEFT HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

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

Patient Problems Headache (1880); Blurred Vision (2137); Confusion/ Disorientation (2553)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

As reported in fda medwatch mw54104269: "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 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 found all my symptoms are metal on metal poisoning, metallosis which was noted in my surgeon's 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 my 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." this pi is for the right hip.

• Brand Name: UNKNOWN LEFT HIP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12750404
• MDR Text Key: 280057125
• Report Number: 0002249697-2021-01828
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention