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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR HIP FEMORAL AUGMENT

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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL SLEEVE ASR
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Rash (2033); Weakness (2145); Anxiety (2328); Deformity/ Disfigurement (2360); Depression (2361); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary. No device associated with this report was received for examination. This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Event Description
Asr xl litigation records received. Plaintiff alleges pain, rashes, memory loss, abnormal chromium level, metal poisoning, weakness, metallosis, metal debris, fear, anxiety, depression and disfigurement. Doi: (b)(6) 2006. Dor: none reported. Right hip.
 
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Brand NameUNK HIP FEMORAL SLEEVE ASR
Type of DeviceHIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD - 8010379
st anthonys road
leeds LS11 8DT
EI LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10080054
MDR Text Key191736864
Report Number1818910-2020-12440
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL SLEEVE ASR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 05/21/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
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