MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 9/10 COCR HEAD 22.225MM +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	152190053
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The tha was performed to the patient on (b)(6) 2006.After the surgery, the inner head was detached because the dislocated was occurred when the patient fell down from the chair.Until then, the patient never had a dislocation.It was reported that the revision surgery was performed on (b)(6) 2018 by replacing the cup and the head.There was little denaturation at the junction, a small amount of black debris was observed, and soft tissue necrosis was not observed.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9/10 COCR HEAD 22.225MM +3
• 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
• MDR Report Key: 7266090
• Report Number: 1818910-2018-53303
• Device Sequence Number: 1826703
• Product Code: JDI
• UDI-Device Identifier: 10603295276586
• UDI-Public: 10603295276586
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 152190053
• Device Lot Number: 2003849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 08/08/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/16/2018; 08/30/2018
• 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