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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR TAP SLV ADAP 11/13 +3; HIP FEMORAL STEM/SLEEVE
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DEPUY INTERNATIONAL LTD. 8010379 ASR TAP SLV ADAP 11/13 +3; HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 999800203
Device Problem Insufficient Information (3190)
Patient Problems Joint Swelling (2356); Claudication (2550); No Information (3190); No Code Available (3191)
Event Date 06/06/2012
Event Type  Injury  
Event Description
Asr revision.Asr xl acetabular system - left hip.Reason(s) for revision: unknown.Update - marked as legal, added kid number, amended implant date, added a sleeve, filed out mw fields and manufacturing dates.Taken from (b)(6) email and spreadsheet both dated (b)(6) 2014.
 
Manufacturer Narrative
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.
 
Event Description
Asr revision, asr xl acetabular system - left hip, reason(s) for revision: unknown.Update - marked as legal, added kid number, amended implant date, added a sleeve, filed out mw fields and manufacturing dates.Taken from (b)(6) email and spreadsheet both dated 9th september 2014.Update - amended implant date, added all expiry dates, querying missing stem details and missing reason for revision.Taken from claimsuite dated the 31st march 2015.- ab 1st april 2014.Surgery date: 09 may 2006 update - received stem details and reasons for revision on 1st april 2015.2nd reason for revision on claimsuite dated 2nd april 2015 reasons for revision : high cobalt and chromium, pain and limp, significant effusion./ alval / soft tissue reaction.
 
Manufacturer Narrative
Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.
 
Event Description
Asr revision.Asr xl acetabular system - left hip.Reason(s) for revision: unknown.Update - marked as legal, added kid number, amended implant date, added a sleeve, filed out mw fields and manufacturing dates.Taken from kennedys email and spreadsheet both dated (b)(6) 2014 update - amended implant date, added all expiry dates, querying missing stem details and missing reason for revision.Taken from claimsuite dated the (b)(6) 2015.- ab 1st april 2014 surgery date: (b)(6) 2006.
 
Manufacturer Narrative
Implant date.Depuy still considers the investigation closed.Should additional information be received the investigation will be reopened.
 
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Brand Name
ASR TAP SLV ADAP 11/13 +3
Type of Device
HIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK   LS11 8 DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key4090607
MDR Text Key4743422
Report Number1818910-2014-28027
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,foreign,other
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 04/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date02/16/2010
Device Catalogue Number999800203
Device Lot Number1843207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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