• 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 MARATHON XLPE CEMENT CUP 28/43 MARATHON XLPE CEMENTED CUP IMPLANTS : HIP POLY ACETABULAR CUPS

  • 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 MARATHON XLPE CEMENT CUP 28/43 MARATHON XLPE CEMENTED CUP IMPLANTS : HIP POLY ACETABULAR CUPS Back to Search Results
Catalog Number 965512843
Device Problem Component Missing (2306)
Patient Problem Not Applicable (3189)
Event Date 04/05/2018
Event Type  malfunction  
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
Ref: (b)(4). Lot: 8655076. Expiry: 2022-10-31. Description: 43mmx28mm marathon cemented cup. This was opened yesterday only to find that the metal retaining clip was too big to correctly fit onto the cup.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMARATHON XLPE CEMENT CUP 28/43
Type of DeviceMARATHON XLPE CEMENTED CUP IMPLANTS : HIP POLY ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7475142
MDR Text Key107126184
Report Number1818910-2018-58558
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue Number965512843
Device Lot Number8655076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-