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,8MM; 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,8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED Back to Search Results
Model Number 400-142F
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 05/05/2021
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 patient had unstable star total ankle.Dr.Steven has assessed the patient and chose a revision poly exchange to increase soft tissue tension to increase stability.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SLIDING CORE, UHMPWE,8MM
Common Device Name
PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key11966704
Report Number0008031020-2021-00257
Device Sequence Number4544044
Product Code NTG
UDI-Device Identifier00886385026947
UDI-Public00886385026947
Combination Product (Y/N)N
Initial Reporter StateWA
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) 06/09/2021
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? Yes
Operator of Device Lay User/Patient
Device Model Number400-142F
Device Catalogue Number400142F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/21/2021
Initial Report FDA Received Date06/09/2021
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 Age59
-
-