MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. REG. # 8010379 ELITE MODULAR HD 28MM +0; HIP FEMORAL HEAD

Catalog Number 962573000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 09/15/2008

Event Type  Injury  

Event Description

Liner and head revised due to dislocations.(b)(6) 2008.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Notification was received from bioengineering stating the root cause is undetermined.Based on the information received and the investigation performed, the root cause of the need for revision was undetermined.The customer did not report a device defect.It is not possible to determine if there was a manufacturing fault.No corrective action is required.Post market surveillance is per sep-419.A review of manufacturing records and a complaint database search did not identify any anomalies.The complaint shall be closed with an undetermined conclusion; it will be entered into the complaint database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.

• Brand Name: ELITE MODULAR HD 28MM +0
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. REG. # 8010379; st. anthony's rd; leeds, leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. REG. # 8010379; st. anthony's rd; leeds, leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3826790
• MDR Text Key: 4504321
• Report Number: 1818910-2014-19336
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK871867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2009
• Device Catalogue Number: 962573000
• Device Lot Number: 1164560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2004
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR