• 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 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL 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 ADAPTER SLEEVES 12/14 +2 HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800312
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)
Event Date 05/08/2017
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 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.
 
Event Description
New unity record created in order to update legacy complaint (b)(4). Litigation alleges that patient suffers from constant hip pain, back pain and discomfort. It is sometimes not possible for patient to perform her routine daily activities due to the pain. The incision site around the hip implant sometimes still opens up and bleeds years after her original implant surgery. Additionally, it is alleged that patient has elevated metal ion levels. Patient's preliminary disclosure form was received on 6/29/2012, which provided part/lot information. Doi: (b)(6) 2008 - dor: none reported (left hip) **patient is a resident of (b)(6). Update nov 15 and 28, 2017: medical records received. After review of medical records for the mdr reportability, in addition to what was previously reported, the patient was revised to address metallosis and trunnionosis. Revision notes reported a metallosis-type fluid, significant trunnionosis with grey metal black particles in the femoral head, and no real incorporation of bone into the acetabular shell. Laboratory result for cobalt is above 7 ppb. Clinical notes reported inability to bear weight, history of wound dehiscence, soft tissue atrophy, limited rom, decreased motor strength, flexed forward ambulation with cane and significant limp. X-ray shows the femoral stem is somewhat proud and slightly varus. Added asr taper sleeve and tri-lock stem. Doi: (b)(6) 2008 dor: (b)(6) 2017 (left hip).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADAPTER SLEEVES 12/14 +2
Type of DeviceHIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's road
leeds IN 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 46582-0988
5743725905
MDR Report Key7114336
MDR Text Key118267414
Report Number1818910-2017-51523
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 consumer,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2013
Device Catalogue Number999800312
Device Lot Number2631025
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 Received07/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/13/2008
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 Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
-
-