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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC Back to Search Results
Catalog Number 625-0T-32F
Device Problem Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's left hip was revised after patient complaint of squeaking eventually patient complaint of a grinding noise.Intra-op and post-op inspections found no fractures, wear, or damage to the ceramic head and liner.No ceramic debris was noted in the patient.Patient was revised to a poly liner with a ceramic head and sleeve.
 
Event Description
It was reported that the patient's left hip was revised after patient complaint of squeaking eventually patient complaint of a grinding noise.Intra-op and post-op inspections found no fractures, wear, or damage to the ceramic head and liner.No ceramic debris was noted in the patient.Patient was revised to a poly liner with a ceramic head and sleeve.
 
Manufacturer Narrative
An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: a material analysis has been performed.The report concluded: damage was observed on the titanium sleeve of the trident alumina insert, consistent with the explantation process.A continuous metal transfer ring was observed at the proximal of the taper.A continuous metal transfer ring indicates proper seating between the head taper and stem trunnion.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other events were reported for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
 
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Brand Name
TRIDENT ALUMINA INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8675561
MDR Text Key147217969
Report Number0002249697-2019-02186
Device Sequence Number1
Product Code MRA
UDI-Device Identifier04546540516855
UDI-Public04546540516855
Combination Product (y/n)N
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 11/27/2019
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 Date08/31/2016
Device Catalogue Number625-0T-32F
Device Lot Number37794102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received06/06/2019
Supplement Dates Manufacturer Received10/31/2019
Supplement Dates FDA Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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