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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; IMPLANT Back to Search Results
Catalog Number 542-11-54F
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Complaint, Ill-Defined (2331)
Event Date 06/04/2014
Event Type  Injury  
Event Description
It was reported that the patient's left hip was previously revised from a rejuvenate modular construct.Stem, neck and head were removed and replaced with competitor product.On (b)(6) 2014, the patient was revised again due to infection.Competitor product was removed along with the patients primary stryker cup and liner.
 
Manufacturer Narrative
Catalogue number unknown at this time.Device description reported as an unknown trident 54mm cup.The unknown liner was also listed in this report.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.
 
Manufacturer Narrative
The device information for unknown liner was replaced with trident 10° x3 insert 36mm id; cat# 623-10-36f; lot# mjm2xy.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Visual, dimensional and functional analysis could not be performed as the device was not returned.The provided medical information was reviewed by a consulting clinician.Lab test results or results of bloodwork for infection were not provided.The patient has an open wound and has undergone several debridements.There is no indication was found that the event was related to device design, materials, or manufacturing.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
 
Event Description
It was reported that the patient's left hip was previously revised from a rejuvenate modular construct.Stem, neck and head were removed and replaced with competitor product.On (b)(6) 2014, the patient was revised again due to infection.Competitor product was removed along with the patients primary stryker cup and liner.
 
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Brand Name
TRIDENT PSL HA CLUSTER 54MM
Type of Device
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 navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3898010
MDR Text Key4672121
Report Number0002249697-2014-02452
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983382
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 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2015
Device Catalogue Number542-11-54F
Device Lot NumberMJEX10
Other Device ID NumberSTERILE LOT# MSHJH22A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2010
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) Required Intervention;
Patient Age77 YR
Patient Weight65
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