• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE(R) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, 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
 

WRIGHT MEDICAL TECHNOLOGY, INC. INBONE(R) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 200009902
Device Problems Break; Disassembly
Event Date 02/06/2017
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation; however, films were supplied for review. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete. Associated with reports 1043534-2017-00024 and 1043534-2017-00025.

 
Event Description

Allegedly, it was reported that the patient underwent an ankle surgical procedure. Approximately 8 months post-op, it was found that the tibial stem implants are disassociated or broken. No additional information is available at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINBONE(R)
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
38002
Manufacturer Contact
1023 cherry road
901451-631
MDR Report Key6368345
Report Number1043534-2017-00026
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number200009902
Device LOT Number1576189
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/06/2017
Event Location Other
Date Manufacturer Received02/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-