• 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 CENTPILLAR TMZF SIZE 5 LEFT HIP IMPLANT

  • 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 CENTPILLAR TMZF SIZE 5 LEFT HIP IMPLANT Back to Search Results
Catalog Number 5353-0-105
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Edema (1820)
Event Date 03/10/2017
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Approx. 5 years ago, left tha surgery using centpillar, trident, metal head was performed. Then, pseudotumor was found on left hip of the patient. Analysis of blood and synovial fluid are planned.
 
Manufacturer Narrative
An event regarding revision due to pseudotumor involving a centpillar stem was reported. The event was not confirmed. Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation. -medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review. -device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies. -complaint history review: there have been no other similar events for the reported lot. Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided. Further information such as return of device, operative reports, xrays, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.
 
Event Description
Approx. 5 years ago, left tha surgery using centpillar, trident, metal head was performed. Then, pseudotumor was found on left hip of the patient. Analysis of blood and synovial fluid are planned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTPILLAR TMZF SIZE 5 LEFT
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6513803
MDR Text Key73679519
Report Number0002249697-2017-01338
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2016
Device Catalogue Number5353-0-105
Device Lot Number37213403
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 Received05/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2011
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: 04/22/2017 Patient Sequence Number: 1
-
-