• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 502-11-54E
Device Problems No Apparent Adverse Event; Insufficient Information
Event Date 02/15/1948
Event Type  Malfunction  
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. 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 voluntary recall was initiated for trident® hemispherical acetabular shells, encompassing all lot codes with an expiration dates between january 1, 2003 and december 31, 2012.

 
Event Description

Patient called stating she had a left hip replacement done on october 24, 2007 and wants to know if her implants are part of a recall. Patient is asymptomatic at the time of this call.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
alessandra chavez
2555 davie road
fort lauderdale , FL 33317
9546280700
MDR Report Key9688799
Report Number0002249697-2020-00255
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2012
Device MODEL Number502-11-54E
Device Catalogue Number502-11-54E
Device LOT Number23447501
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/11/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1168/74-2008

Patient TREATMENT DATA
Date Received: 02/10/2020 Patient Sequence Number: 1
-
-