Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 POLYETHYLENE RMVL TOOL; 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 POLYETHYLENE RMVL TOOL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 2112-0010
Device Problems Device Inoperable (1663); Material Deformation (2976); Naturally Worn (2988)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 01/19/2016
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted, upon completion of the investigation.
 
Event Description
During a primary right hip when surgeon was implanting the screw into the shell, the threads wore down rendering the universal screwdriver no longer useable.During the same case, the surgeon had to remove the poly for adjustment and the threads on the poly were worn down rendering the device no longer useable.No delay or adverse consequence to the patient and the surgery completed without any other issues.
 
Manufacturer Narrative
An event regarding damage involving a trident polyethylene removal tool was reported.The event was confirmed.Method and results: device evaluation and results: material analysis indicated the outermost threads of the rmvl tool were damaged.Evidence of metal transfer in the damaged region was observed, likely from contact with an acetabular shell.No material or manufacturing defects were observed on the fracture surface examined.Medical records received and evaluation: medical records were not provided.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for lot and sterile lots.Conclusion: the investigation concluded that the examination of the deformed threads was confirmed to be consistent with the same product and issue of a similar complaint.It was concluded with the mar that the evidence of metal transfer in the damaged region was observed, likely from contact with an acetabular shell.No material or manufacturing defects were observed on the surface examined.
 
Event Description
During a primary right hip when surgeon was implanting the screw into the shell, the threads wore down rendering the universal screwdriver no longer useable.During the same case, the surgeon had to remove the poly for adjustment and the threads on the poly were worn down rendering the device no longer useable.No delay or adverse consequence to the patient and the surgery completed without any other issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT POLYETHYLENE RMVL TOOL
Type of Device
PROSTHESIS, 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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5454747
MDR Text Key39263250
Report Number0002249697-2016-00438
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151264
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 01/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2112-0010
Device Lot NumberF8W744810
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2016
Initial Date FDA Received02/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-