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

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 MOB ANKLE BEAR 3 X 7MM MOBILITY ANKLE SYSTEM : ANKLE TIBIAL

  • 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
 

DEPUY INTERNATIONAL LTD. 8010379 MOB ANKLE BEAR 3 X 7MM MOBILITY ANKLE SYSTEM : ANKLE TIBIAL Back to Search Results
Catalog Number 955505307
Device Problem Insufficient Information
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Exchange of liner - mobility ankle + calcaneal osteotomy + internal brace: (b)(6) 2018. As per surgeon - liner loose, ankle joint showing osteolysis. No primary date known. No further details available via surgeon or patient notes. On removal the liner appeared worn on the lateral aspect as would be expected looking at the x-ray. Jnj representative was present at the case. Female patient (b)(6).

 
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). Investigation summary no device associated with this report was received for examination. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMOB ANKLE BEAR 3 X 7MM
Type of DeviceMOBILITY ANKLE SYSTEM : ANKLE TIBIAL
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7565116
Report Number1818910-2018-61225
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number955505307
Device LOT NumberSA7871
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/04/2018 Patient Sequence Number: 1
-
-