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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP LINER METAL
Device Problem Noise, Audible (3273)
Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/01/2020
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. Remedial actn initiated othr type 2nd.
 
Event Description
The patient has a left metal on metal hip since in 2008, the hip has been making grinding noises and has been leaking metals (ions) into my blood for over 12 years, these metals are called cobalt and chromium, these metals are in my blood system. This is called metal poisoning. (metallosis), in the last 2 years, the pain in my left hip and leg has gotten worse to the point that i have had to stop walking because of excruciating pain to my hip on many occasions, i also started to experience fatigue depression, anxiety attacks, pain in left leg, mobility issues, breathing difficulties when walking, kidney damage, liver damage, thyroid problems and metal poisoning to blood and endocrine system, vision worse. My ion levels are very high, cobalt is 574 nmol/l and chromium is 650 nmol/l,within the past four months my eyesight has gotten w orse, my anxiety levels and breathlessness have increased and so has my mobility has lessened and is deteriorating.
 
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Brand NameUNK HIP ACETABULAR LINER METAL
Type of DeviceMETAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12212117
MDR Text Key262960581
Report Number1818910-2021-15777
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 consumer,foreign
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP LINER METAL
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
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