MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Toxicity (2333); Test Result (2695); No Code Available (3191)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is a report for the patient right tha.Her right total hip arthroplasty was performed in 2010 and left in 2011.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 become progressively painful in 2018.By 2018 she elected to have the left hip revised by a surgeon.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 notices more lateral soreness at the right hip.Her cobalt levels remain elevated on 2018.Her urine cobalt level was 16.6 mcg/l and urine chromium level was 50.2 mcg/l on 2019.Her urine cobalt level was 27.63 mcg/l and blood cobalt level was 4.6 mcg/l in 2019.She began taking 600 mg of n-acetyl cysteine three times per day for potential cobalt chelation since hip replacement.She has 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 should focal and general hypertension suggestive of chronic toxic encephalopathy and different from patterns seen for patients experiencing fronto temporal dementias, alzheimers disease or normal aging.Doi: (b)(6) 2011, dor: (b)(6) 2018, left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9823642
• MDR Text Key: 188632645
• Report Number: 1818910-2020-07569
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention