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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Device Dislodged or Dislocated; Material Deformation
Event Date 06/23/2018
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

It was reported through the submission of a revision implant sheet that patient's hip was revised. The only reported device on the implant sheet is a ball-tipped guide wire. Sales rep has confirmed that an accolade tmzf stem and metal head were revised due to a worn stem trunnion and head stem disassociation.

 
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Brand NameUNKNOWN ACCOLADE TMZF 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
diana avila
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7700731
Report Number0002249697-2018-02221
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2018
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: 07/18/2018 Patient Sequence Number: 1
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