• 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 EXETER V40 STEM 44MM NO 2 HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

  • 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 EXETER V40 STEM 44MM NO 2 HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Back to Search Results
Catalog Number 0580-1-442
Device Problems Bent (1059); Fitting Problem (2183); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  Malfunction  
Manufacturer Narrative

Review of the product history records indicate that devices were manufactured and accepted into stock no relevant reported discrepancies. There have been no other events for the lot referenced. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

This spigot is placed on the cone of an exeter stem to be able to fix the stem at the stem introducer. It seems like the spigot is too big, it has problems to get into the stem inserter, which gives the spigot a twist and then it is not able to get into the stem inserter. The spigot is only to place the stem at the stem inserter, afterwards it is going to be thrown away, but it is quite hard to fix the stem in the stem inserter when the spigot is broken/twisted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXETER V40 STEM 44MM NO 2
Type of DeviceHIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7181590
MDR Text Key96950091
Report Number0002249697-2018-00126
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
PMA/PMN NumberK121308
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 05/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0580-1-442
Device LOT NumberG7209615
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2017
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: 01/11/2018 Patient Sequence Number: 1
-
-