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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 Problems Malposition of Device (2616); Material Deformation (2976); Noise, Audible (3273)
Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Foreign Body In Patient (2687)
Event Date 07/26/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that after a fall approximately a year previously (to (b)(6) 2017), the patient began experiencing pain, limited motion, and a lot of squeaking.Upon taking x-rays, the surgeon reported that the ball was riding off-center (superior) to the shell.Upon performing revision, the surgeon reported that there was eccentric wear, and shards from the ceramic head were discovered in the patient.Procedure was reported to have been performed successfully with no surgical delay.
 
Manufacturer Narrative
An event regarding pain, range of motion issues and squeaking involving a trident liner was reported.Liner fracture was confirmed.Device evaluation and results: a visual inspection was performed as part of the material analysis.The mar indicated that "damage was observed on the insert, consistent with contact against the ceramic head." the mar concluded: "no material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a mar was performed and concluded "no material or manufacturing defects were observed on the surfaces examined."the exact cause of the event however could not be determined because insufficient information was provided.Further information such as operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported that after a fall approximately a year previously (to (b)(6) 2017), the patient began experiencing pain, limited motion, and a lot of squeaking.Upon taking x-rays, the surgeon reported that the ball was riding off-center (superior) to the shell.Upon performing revision, the surgeon reported that there was eccentric wear, and shards from the ceramic head were discovered in the patient.Procedure was reported to have been performed successfully with no surgical delay.
 
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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
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6807587
MDR Text Key83145655
Report Number0002249697-2017-02561
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/06/2009
Device Catalogue Number625-0T-32F
Device Lot Number9898001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2004
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;
Patient Age62 YR
Patient Weight66
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