• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY INTERNATIONAL LTD. 8010379 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 999800105
Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Further investigation of this individual incident will not be undertaken. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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. 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.
 
Event Description
Patient underwent a revision to address alval/soft tissue reaction, pseudotumor, noise, elevated metal ions and pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLARGE MOD HEAD ADAPT 12/14 +5
Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
MDR Report Key6257851
MDR Text Key189283692
Report Number1818910-2017-11078
Device Sequence Number1
Product Code KWY
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,Followup
Report Date 12/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999800105
Device Lot Number2273902
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 01/17/2017 Patient Sequence Number: 1
-
-