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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem 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 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.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9825949
MDR Text Key183251741
Report Number1818910-2020-07697
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
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 Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2020 Patient Sequence Number: 1
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