• 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 ASR ACETABULAR CUPS 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

  • 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 ASR ACETABULAR CUPS 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800754
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Local Reaction (2035); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 03/02/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter 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 medical records received. After review of medical records the patient was revised due to pain and elevated metal ions. Operative note reported straw colored fluid present in the joint and slightly murky consistent with adverse reaction to metal debris, hypertrophic synovium, pseudotumor, hemosiderin stain, metal staining and some trunnionosis. There was some trunnoinosis and metal debris on the trunnion itself. Another event was reported a competitor head would not stay on the trunnion due to adaptor sleeve size was the wrong size to fit on the trunnion. However, decided not to removed the well fixed stem which may add another hours to the case. The head component that did not fit appropriately during revision was temporary left in the patient and proceeded to a second stage procedure to re-implant the correct sized femoral head (competitor). Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
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.   if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameASR ACETABULAR CUPS 54
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
1210 ward avaenue
west chester, PA 19380-0988
6103142063
MDR Report Key9416797
MDR Text Key185094591
Report Number1818910-2019-120747
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2013
Device Catalogue Number999800754
Device Lot Number2553229
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 Received01/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2008
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: 12/05/2019 Patient Sequence Number: 1
-
-