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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSTRUMENT HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Device Operates Differently Than Expected
Event Date 06/14/2017
Event Type  Malfunction  
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

During a restoration modular hip revision, the surgeon was turning the jack screw into the cone body and the taper did not break. The surgeon had to remove the modular construct as one piece. The surgeon then proceeded with a competitors proximal femur replacement.

 
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Brand NameUNKNOWN INSTRUMENT
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 Key6711396
Report Number0002249697-2017-02190
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SHC
Device LOT NumberUNKNOWN
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 Received08/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/13/2017 Patient Sequence Number: 1
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