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 CORP./HOWMEDICA OSTEONICS CORP. CUP; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
  • 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 CORP./HOWMEDICA OSTEONICS CORP. CUP; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 07/03/2023
Event Type  malfunction  
Event Description
Patient had a revision earlier last month due to unknown reason.Stryker cup moved and converted to stryker mdm.It is unknown if there was any surgical delay.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CUP
Type of Device
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER CORP./HOWMEDICA OSTEONICS CORP.
MDR Report Key17287393
MDR Text Key318707062
Report NumberMW5119218
Device Sequence Number1
Product Code KWZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Patient Sequence Number1
-
-