MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY PROSTHESIS HIP; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Device Problem Noise, Audible (3273)

Patient Problems Calcium Deposits/Calcification (1758); Cyst(s) (1800); Pain (1994); Numbness (2415); Sleep Dysfunction (2517); Weight Changes (2607); Taste Disorder (4422); Swollen Lymph Nodes/Glands (4432); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

My 14 year old depuy prosthetic hip has bothered me for about 5 years.I haven't felt well for 3-4 years and i've felt awful since (b)(6) 2020.I get very little sleep due to pain in different areas.I've had a variety of unusual painful symptoms and a few of these symptom's include metal taste in mouth for months, horrible stomach pains, painful lumps/pouches of fluid that appear suddenly at different times, red eyes with dilated blood vessels in corners of eyes, enlarged lymph node in neck has been monitored for a couple years, painful numb feet with nodules and redness on bottom of feet, squiggly blood vessels, two tiny cysts on thyroid, painful nodules and lumps throughout my body, abnormal urine tests in (b)(6), iron deficiency without anemia for a couple years (low transferrin saturation level that was 10 recently but high ferritin level for a couple of years) along with many other unexplained painful symptoms and new symptoms occur almost daily.I've lost 20 lbs as it's hard to eat because of the stomach pain.I continue to decline and disagree with my pcp np saying depression can be the cause for these bazaar symptoms since no cause has been determined.I ask my pcp np to order metal poisoning blood tests but the cobalt test was denied as it was beyond her authority.I had two abdominal cts done and one showed "calcification" on bladder dome and/or infection or inflammation of the bladder and or adjacent colon.Cysto ruled out bladder stones but i still have no answer for what appeared on ct a couple months ago.A 2nd ct indicated something small on the liver that could possibly be a hemangioma.My original orthopedic surgeon said my prosthetics done in 2005 and 2007 could last 10-15 years but the orthopedic that replaced him told me a 2nd time in (b)(6), 2019 that my prosthetics are fine and will last a long time.He told me xray indicated it was tendonitis in 2019.My prosthetic makes cracking sounds when moving certain ways and i haven't been able to lay on my right side due to pain for a few years.I have a 2nd opinion appointment scheduled with an orthopedic revision doctor but i fear the 2nd opinion orthopedic will agree with orthopedic i see within the same practice as a phone conversation with a pa at this practice last month said it's rare to have metal poisoning.Please let me know if there is a legitimate accurate place where a patient can get metal poisoning blood tests done without a doctor's script.I would just like metal poisoning ruled out since i'm declining daily with new symptoms appearing with no diagnosis.I fear doctors have missed something and that a serious issue will occur very soon due to my wide variety of symptoms.Thank you.(b)(6).Fda safety report id# (b)(4).

• Brand Name: DEPUY PROSTHESIS HIP
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 11529329
• MDR Text Key: 241488014
• Report Number: MW5100122
• Device Sequence Number: 1
• Product Code: KWY
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1