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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number 542-11-42B
Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
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
42mm trident cup was revised for loosening. Initial surgery was done 15/4/16 - surgeon reported an intra operative acetabular fracture, which did not heal and led to cup loosening.
 
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Brand NameTRIDENT PSL WITH PUREFIX HA
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood, FL WD6 3-SJ
UK   WD6 3SJ
9546280700
MDR Report Key10779484
MDR Text Key214378662
Report Number0002249697-2020-02304
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K983382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2019
Device Model Number542-11-42B
Device Catalogue Number542-11-42B
Device Lot Number49494301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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