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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 53; HIP FEMORAL HEAD
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DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 53; HIP FEMORAL HEAD Back to Search Results
Catalog Number 999890153
Device Problems Metal Shedding Debris (1804); Malposition of Device (2616)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 02/19/2014
Event Type  Injury  
Event Description
Asr revision due to take place (b)(6) 2013.Asr xl - right.Reason(s) for revision: pain, component loosening - and component malalignment.Cup implant date: (b)(6) 2006.Xl products implant date: (b)(6) 2006.Please note stem in non depuy product - this com is to be closed to capa due to the reasons for revision falling within the capa remit and off label use of a competitor stem.This patient has undergone a resurfacing to xl procedure - please see (b)(4) for the 1st revision.Update received: (b)(4) 2013 - added which component became loose: stem.Re-opened (b)(4) 2014 - update mandatory fields and request information.Update received: (b)(4) 2014 - attached operative notes document, added further revision reason: metalosis and added patient details: name, age and date of birth.Update received: (b)(4) 2014 - added patient height and weight and attached translated post operative note.Update received: (b)(4)2014 - re-opened to attach x-rays and close second request for information action activity.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Ref.Wwcapa (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.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.
 
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 due to take place (b)(6) 2013, asr xl - right, reason(s) for revision: pain, component loosening - and component malalignment.Cup implant date: (b)(6) 2006.Xl products implant date: (b)(6) 2006.Please note stem in non depuy product - this com is to be closed to capa due to the reasons for revision falling within the capa remit and off label use of a competitor stem this patient has undergone a resurfacing to xl procedure - please see com (b)(4) for the 1st revision.Update received: (b)(6) 2013 - added which component became loose: stem.Re-opened (b)(6) 2014 - update mandatory fields and request information.Update received: (b)(6) 2014 - attached operative notes document, added further revision reason: metallosis and added patient details: name, age and date of birth.Update received: (b)(6) 2014 - added patient height and weight and attached translated post operative note.Update received: (b)(6) 2014 - re-opened to attach x-rays and close second request for information action activity.Update received: (b)(6) 2014 - added (b)(6) reference number, marked as legal, added manufacturing dates and added hospitals: (b)(6).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).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.Device history lot - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient code: no code available ((b)(4)) used to capture the device revision or replacement.
 
Event Description
This is to captured the updated harm and codes.
 
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Brand Name
DEPUY ASR XL FEM IMP SIZE 53
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key3646259
MDR Text Key4197949
Report Number1818910-2014-13273
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 Other,Foreign,foreign,other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number999890153
Device Lot Number1236493
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/20/2014
Initial Date FDA Received02/25/2014
Supplement Dates Manufacturer ReceivedNot provided
03/06/2020
04/06/2020
Supplement Dates FDA Received03/10/2014
03/31/2020
04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight90
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