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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; 04546540432070
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; 04546540432070 Back to Search Results
Catalog Number 502-11-60G
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348)
Event Date 05/10/2018
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.Not returned.
 
Event Description
It was reported that patient's left hip was revised due to instability and trunnion wear.The patient was revised to a competitor stem, the stryker shell and liner were not revised.Per sales rep: ".The shell locking mechanism was compromised.They ended up cementing in a competitive poly liner.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation (locking mechanism failure for the shell) involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant concluded : review of these records confirms revision surgery for trunnion wear with dissociation of the femoral head from the trunnion of the femoral did occur.The root cause cannot be determined as insufficient information was available.Tha instability related to dissociation of the femoral head from the trunnion of the femoral occurred as well.The root cause cannot be determined as insufficient information was available.Further documentation required for completion of this assessment would include: dated pre and post op xrays from the index and revision surgeries, implant retrieval.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that patient's left hip was revised due to instability and trunnion wear.A review of the provided medical records by the consulting clinician concluded that review of these records confirms revision surgery for trunnion wear with dissociation of the femoral head from the trunnion of the femoral did occur.The root cause cannot be determined as insufficient information was available.Tha instability related to dissociation of the femoral head from the trunnion of the femoral occurred as well.The root cause cannot be determined as insufficient information was available.The reported issue for the failure of the locking mechanism for the shell could not be confirmed.Ino further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not available.
 
Event Description
It was reported that patient's left hip was revised due to instability and trunnion wear.The patient was revised to a competitor stem, the stryker shell and liner were not revised.Per sales rep: ".The shell locking mechanism was compromised.They ended up cementing in a competitive poly liner.".
 
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Brand Name
TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
Type of Device
04546540432070
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7587685
MDR Text Key110637762
Report Number0002249697-2018-01755
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2011
Device Catalogue Number502-11-60G
Device Lot Number20783501
Was Device Available for Evaluation? No
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
Patient Weight109
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