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 GMBH SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
  • 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 GMBH SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Model Number 400-140F
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event or Problem Description
It was reported the poly was swapped.No further details regarding the revision were provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
Common Device Name
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key12512403
Report Number0008031020-2021-00417
Device Sequence Number19107848
Product Code NTG
UDI-Device Identifier00886385026923
UDI-Public00886385026923
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P050050
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/22/2021
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 Lay User/Patient
Device Model Number400-140F
Device Catalogue Number400140F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date09/22/2021
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 Required Intervention;
Patient Age67 YR
-
-