Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 UNI FEMORAL IMPL SIZE 47; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
  • 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 UNI FEMORAL IMPL SIZE 47; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890247
Device Problems Corroded (1131); Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 03/14/2018
Event Type  Injury  
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.
 
Event Description
Asr litigation records received alleging injury, economic loss, loss of consortium, pain, metallosis, swelling, inability to walk/stand/sit, inability to self-care, excessive levels of chromium and cobalt in the blood, suffering and emotional distress.Doi: (b)(6) 2009 - dor: (b)(6) 2018 (left hip).
 
Manufacturer Narrative
(b)(4).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, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional 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.  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.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, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).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.No code available ((b)(4)) used to capture device revision or replacement.
 
Event Description
Revision notes stated that clear yellow synovial fluid was noted and not appear purulent.There were some trunnionosis noted.Black staining of the trunnion was removed.Head was removed.Added patient's age and medical history.
 
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.H6 patient code: no code available (3191) used to capture the walking difficulty and device revision or replacement.
 
Event Description
Update ad 3 apr 2020: litigation records received.Litigation records alleges hip pain, metallosis, swelling, inability to walk, stand, and sit, inability to care for self, injuries, elevated metal ions, suffering, emotional distress, and economic loss.Update ad 6 apr 2020: medical records received.After review of medical records, patient was revised to address painful asr left total hip arthroplasty with elevated cobalt and chromium levels.Patient alleges pain and mechanical popping.Revision notes stated that with slight internal rotation, the scar tissue was released off the bony insertion through a standard posterolateral approach.Capsulotomy was performed on the capsule exposing clear yellow synovial fluid.This fluid did not appear purulent.The asr femoral head was removed from the trunnion.There was some trunionnosis noted.The black staining on the trunnion was removed with a bovie pad.Head and liner were removed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASR UNI FEMORAL IMPL SIZE 47
Type of Device
ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key9615934
MDR Text Key175867394
Report Number1818910-2020-02471
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number999890247
Device Lot Number3003297
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2020
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 Age58 YR
-
-