MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 MARATHON XLPE CEMENT CUP 28/43; MARATHON XLPE CEMENTED CUP IMPLANTS : HIP POLY ACETABULAR CUPS

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.

• Brand Name: MARATHON XLPE CEMENT CUP 28/43
• Type of Device: MARATHON 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 Key: 7475142
• MDR Text Key: 107126184
• Report Number: 1818910-2018-58558
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 965512843
• Device Lot Number: 8655076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/04/2018; 07/16/2018
• Supplement Dates FDA Received: 05/09/2018; 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1