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 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.
 
Manufacturer Narrative
An event regarding an assembly issue involving an exeter stem with spigot was reported.The event was confirmed.Conclusions: the exact cause of the event could not be determined.If further information becomes available or the product is returned, this investigation will be re-opened.
 
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 Name
EXETER V40 STEM 44MM NO 2
Type of Device
HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7181590
MDR Text Key96950091
Report Number0002249697-2018-00126
Device Sequence Number1
Product Code LPH
UDI-Device Identifier04546540153319
UDI-Public04546540153319
Combination Product (y/n)N
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
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 Expiration Date11/09/2022
Device Catalogue Number0580-1-442
Device Lot NumberG7209615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Date Manufacturer Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-