MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ELITE MODULAR HD 28MM +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	962573000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Right thr, dr (b)(6), (b)(6) hospital (b)(6) 2017.Primary implant (b)(6) 2003 - (b)(6) hospital, dr (b)(6).Revision for pain.Female patient initials (b)(6).Doi:2003; dor:(b)(6) 2017; right hip.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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.
Additional Manufacturer Narrative
This correction is being submitted to correct the sequential numbering for the follow up reports #1 and #2.Follow up #3 submitted on 2/6/2018 should have been submitted as follow up #1.Follow up # 4 submitted on 2/14/2018 should have been submitted as follow up #2.Follow up # 5 submitted on 8/30/2018 should have been submitted as follow up #3 although it appears there are gaps in the sequential follow-up numbers, there are no missing reports.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This correction is being submitted to correct the sequential numbering for the follow up reports #1 and #2.Follow up #3 submitted on 2/6/2018 should have been submitted as follow up #1.Follow up # 4 submitted on 2/14/2018 should have been submitted as follow up #2.Follow up # 5 submitted on 8/30/2018 should have been submitted as follow up #3 although it appears there are gaps in the sequential follow-up numbers, there are no missing reports.

• Brand Name: ELITE MODULAR HD 28MM +0
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7160589
• Report Number: 1818910-2018-50117
• Device Sequence Number: 16505798
• Product Code: JDI
• UDI-Device Identifier: 10603295243168
• UDI-Public: 10603295243168
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 1061923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 07/19/2019; 08/12/2019; 08/12/2019; 08/12/2019; 08/12/2019
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 08/08/2019; 08/12/2019; 02/06/2018; 02/14/2018; 08/30/2018
• Date Device Manufactured: 11/03/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female