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 UNITRAX MODULAR ENDO HEAD 45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
  • 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 UNITRAX MODULAR ENDO HEAD 45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Catalog Number 6942-5-045
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Injury (2348); Joint Dislocation (2374)
Date of Event 02/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
 
Event or Problem Description
It was reported that patient's right hip was revised due to a dislocated hemi construct.The patient was revised to a total hip.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNITRAX MODULAR ENDO HEAD 45MM
Common Device Name
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7373896
Report Number0002249697-2018-00887
Device Sequence Number1146431
Product Code KWL
UDI-Device Identifier07613327032390
UDI-Public07613327032390
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K014226
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number6942-5-045
Device Lot Number8Y555W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2018
Initial Report FDA Received Date03/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Weight45
-
-