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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Degraded; Device Dislodged or Dislocated; Material Deformation
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Hip revised due to head disassociation. After accessing the hip implant black particulate infiltration of tissue was noted as well as worn trunnion.

 
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Brand NameUNKNOWN ACCOLADE TMZF
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
juana hiciano
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key8245504
Report Number0002249697-2019-00175
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
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: 01/14/2019 Patient Sequence Number: 1
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