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

Catalog Number	962573000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address due to dislocation.Update 8/3/2017.It is noted within the additional information that a cup with screws was also revised in this revision surgery.No part and lot were provided but it appears that it may have been a competitor cup and screws (mah: kyocera)--additional product follow-up is being initiated to clarify.Further reporting may follow based upon any information retrieved.Currently, there is not enough information to determine if these products were sold in the us.Complaint updated on: 9/1/2017.
Additional Manufacturer Narrative
The patient was revised to address implant loosening.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELITE MODULAR HD 28MM +0
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6838292
• Report Number: 1818910-2017-24011
• Device Sequence Number: 18861342
• Product Code: JDI
• UDI-Device Identifier: 10603295243168
• UDI-Public: 10603295243168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 962573000
• Device Lot Number: 2932384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention