MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE; PROSTHESIS, HIP SEMI-CONSTRAINED, METAL/ CERAMIC/ POLYMER, CEMENTED

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Arthritis (1723); Atrial Fibrillation (1729); Emotional Changes (1831); Headache (1880); Hearing Loss (1882); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Toxicity (2333); Sleep Dysfunction (2517)

Event Date 12/26/2018

Event Type  Injury  

Event Description

Pt id: (b)(6).This is a report for the patient right tha.Her right total hip arthroplasty was performed in (b)(6) 2010 and the left in (b)(6) 2011, and both were indicated for osteoarthritis of both hips.These hips were both depuy pinnacle ceramic-on-metal hips.The right hip felt good and worked well after the hip replacement, but she says the left hip never felt good.The left hip clicking progressed and she states she was told that this was due to a problem at her iliopsoas tendon.So the left iliopsoas tendon was surgically released, but the hip continued to click despite this procedure.The left hip began subluxating and became progressively painful in (b)(6) 2018.By (b)(6) 2018, she elected to have the left hip revised by a surgeon in (b)(6).She reports that this surgeon found excessive evidence of adverse reaction to metallic debris at this surgery.Around the time of her left hip revision, her metal levels were checked and her blood and urine cobalt levels were found to be significantly elevated.Her right hip still has a pinnacle ceramic-on-metal articulation.Within the past few months, she had increased her physical therapy and has noticed more lateral soreness at the right hip.Her cobalt levels remain elevated.On (b)(6) 2018, her urine cobalt level was 16.6 mcg/l and urine chromium level was 50.2 mcg/l.On (b)(6) 2019, her urine cobalt level was 27.63 mcg/l and blood cobalt level was 4.6mcg/l.In (b)(6) 2019, she began taking 600mg of n-acetyl cysteine threes times per day for potential cobalt chelation.Since hip replacement, she has also been experiencing ocular migraines, tinnitus and hearing loss, sleep issues, memory problems, mood disorder, and atrial fibrillation.These symptoms are consistent with cobalt toxicity.Neuro q analysis of her fdg pet brain scan study showed focal and general hypertension suggestive of chronic toxic encephalopathy and different from patterns seen for patients experiencing frontotemporal dementias, alzheimer¿s disease, or normal aging.Fda safety report id # (b)(4).

• Brand Name: DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE
• Type of Device: PROSTHESIS, HIP SEMI-CONSTRAINED, METAL/ CERAMIC/ POLYMER, CEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 9671640
• MDR Text Key: 178140562
• Report Number: MW5092772
• Device Sequence Number: 2
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/31/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 57