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

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM HIP IMPLANT

  • 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
 

STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Degraded (1153); Material Deformation (2976)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding wear (metallosis and trunnionosis) involving an unknown accolade stem was reported. The event was not confirmed. Method & results: product evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. Medical records received and evaluation: no medical records or x-rays were made available for evaluation. Product history review: not performed as the device was not properly identified. Complaint history review: not performed as the device was not properly identified. Conclusions: the event could not be confirmed nor the root cause determined as insufficient information was provided. The patient was revised due to trunnionosis and metallosis. However, the unknown accolade stem remained implanted. Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.
 
Event Description
Removal of femoral head and liner. Patient complained of pain. The patient was revised due to trunnionosis and metallosis but the accolade stem was left implanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN ACCOLADE STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7685273
MDR Text Key113889273
Report Number0002249697-2018-02163
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2018 Patient Sequence Number: 1
-
-