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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Test Result (2695); No Code Available (3191)
Event Date 10/12/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. Occupation: lawyer. (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
Asr (b)(6) claim letter record received. Patient had elevated metal ion and metalosis.
 
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Brand NameUNKNOWN HIP FEMORAL AUGMENT
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 INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10592887
MDR Text Key208755642
Report Number1818910-2020-20975
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
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 Received10/02/2020
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 09/28/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
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