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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; IMPLANT Back to Search Results
Catalog Number 6020-3535
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 12/08/2014
Event Type  Injury  
Event Description
It was reported that patient had accolade tmzf stem and adm head revised due to loose stem.
 
Manufacturer Narrative
It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.
 
Manufacturer Narrative
An event regarding stem loosening involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.-medical records received and evaluation: insufficient information was received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, x-rays, operative reports and patient medical records would be helpful in investigating this event further.
 
Event Description
It was reported that patient had accolade tmzf stem and adm head revised due to loose stem.
 
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Brand Name
ACCOLADE 132 SIZE 3.5
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4357617
MDR Text Key19345572
Report Number0002249697-2014-04968
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2016
Device Catalogue Number6020-3535
Device Lot Number36846802
Other Device ID NumberSTERILE LOT 1105MCM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2015
Initial Date FDA Received12/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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