MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 MARATHON XLPE CEMENT CUP 32/47; MARATHON XLPE CEMENTED CUP IMPLANTS : HIP POLY ACETABULAR CUPS

Catalog Number 965513247

Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

Femur fractured with impaction of the srom hip femoral stem trial into the sleeve trial.Surgeon lorcan mcgonagle used cables for the fracture.Marathon cup was cemented in and became loose then a g7 uncemented cup was implanted over the marathon cup.

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).After additional review of the product complaint the marathon cup wasn't loose, but instead the joint was noted to be loose/unstable.The marathon cup wasn't revised, but instead a competitor cup was implanted over the cup.It is reasonable to conclude the marathon cup wasn't loose, but instead the joint was loose as the surgeon wouldn't have left a loose cup implanted.There has been no malfunction or serious injury at this time as the intra-op change to improve stability part of trialing.

• Brand Name: MARATHON XLPE CEMENT CUP 32/47
• 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 INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15679245
• MDR Text Key: 303240488
• Report Number: 1818910-2022-21375
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 965513247
• Device Lot Number: 8978256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male