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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE FEMORAL STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 05/09/2017
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

An incident was reported regarding a revision of an accolade femoral stem due to possible trunionosis.

 
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Brand NameUNKNOWN ACCOLADE FEMORAL 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 NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6672936
MDR Text Key78570692
Report Number0002249697-2017-02050
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SHC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
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: 06/28/2017 Patient Sequence Number: 1
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