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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL HEAD UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Mechanical Problem; Device Dislodged or Dislocated
Event Date 07/08/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding crack/fracture involving an accolade stem and unknown femoral head was reported. Crack/fracture was not confirmed however disassociation was confirmed on review of the provided medical records by a clinical physician. Method & results: device evaluation and results: the device was not returned however a photo of the explanted stem was provided, this showed damage on the trunnion of the stem consistent with loss of taper lock with the metal head. Medical records received and evaluation: a review of the provided medical records by a clinical consultant noted; conclusion of assessment. Review of these records confirms dissociation of a femoral head and trunnion with significant damage and loss of material on the superior aspect of the trunnion along with notching and loss of material from the inferior aspect of the neck occurred, however, the root cause cannot be determined as insufficient information was available conclusion: a medical review confirmed disassociation however the root cause could not be determined. Further information such as operative reports, surgical implant records from the surgeries, dated pre and post op x-rays/ imaging from the index and revision surgeries, outpatient office/clinic notes & implant retrieval with material analysis are needed to investigate this event further. If additional information and/or device becomes available, this investigation will be reopened.

 
Event Description

Fractured neck of prosthesis. Update per med review: stem and head disassociation were confirmed per provided images.

 
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Brand NameUNKNOWN FEMORAL HEAD
Type of DeviceUNKNOWN HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key8091248
Report Number0002249697-2018-03785
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
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 Received10/24/2018
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: 11/20/2018 Patient Sequence Number: 1
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