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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 58 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 58 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999805158
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 10/21/2005
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). (b)(4). Initial reporter occupation: lawyer. 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. (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

Pfs and sticker sheet record received. Pfs alleges pain, shortening, misposition and walking difficulty. Doi: aug 12, 2005; dor: oct 21, 2005; right hip.

 
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Brand NameASR ACETABULAR IMPLANT 58
Type of DeviceASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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 Key9747118
MDR Text Key180653892
Report Number1818910-2020-05826
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2010
Device Catalogue Number999805158
Device LOT Number1851925
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2005
Is The Device Single Use? No
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: 02/24/2020 Patient Sequence Number: 1
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