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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Foreign Body Reaction (1868); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Discomfort (2330); Toxicity (2333); Test Result (2695); No Code Available (3191)

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

Patient's 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.Patient has 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.Patient's 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) 2010.Dor: unknown.Right 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.H10 additional narrative: 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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9825947
• MDR Text Key: 188876941
• Report Number: 1818910-2020-07696
• Device Sequence Number: 1
• Product Code: KWA
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention