• 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 37.5MM NO 2 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 EXETER V40 STEM 37.5MM NO 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 0580-1-372
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2017
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. Not available.

 
Event Description

It has been reported that the yellow plastic clip was bent and therefore the stem could not be loaded onto the introducer.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXETER V40 STEM 37.5MM NO 2
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-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6953126
MDR Text Key90203159
Report Number0002249697-2017-03024
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeGB
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 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0580-1-372
Device LOT NumberG7039780
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 Received01/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2017
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: 10/16/2017 Patient Sequence Number: 1
-
-