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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 6260-5-232
Device Problems Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Patient Problems Foreign Body Reaction (1868); Ambulation Difficulties (2544); Metal Related Pathology (4530)
Event Date 08/01/2023
Event Type  Injury  
Event Description
The neck of the accolade tmzf was damaged due to wear, which caused the metal head to come off.Metalosis was also confirmed during revision surgery.
 
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Manufacturer Narrative
Reported event: an event regarding disassociation, wear & metallosis involving a metal head was reported.The event was confirmed.Method & results: -product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." -product history review: device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.It was reported that the patient was confirmed due to disassociation, wear and metallosis.A review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
The neck of the accolade tmzf was damaged due to wear, which caused the metal head to come off.Metalosis was also confirmed during revision surgery.
 
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Brand Name
32MM +4 V40 TAPER VIT HEAD
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI   NA
Manufacturer Contact
sanjana talathi
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17609800
MDR Text Key321801376
Report Number0002249697-2023-00926
Device Sequence Number1
Product Code JDI
UDI-Device Identifier07613327012903
UDI-Public07613327012903
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Catalogue Number6260-5-232
Device Lot Number38443001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2023
Initial Date FDA Received08/24/2023
Supplement Dates Manufacturer Received12/06/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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