MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 26MM +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	152190056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes japan reports an event as follows: it was reported that on (b)(6), 2023, the primary surgery was performed with a duraloc 48mm, aml #12, and a 9/10 cocr head 26mm +3.Patient experienced a dislocation and a revision surgery will be performed to replace the head and cup.No further information is available.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9/10 COCR HEAD 26MM +3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17396700
• Report Number: 1818910-2023-15223
• Device Sequence Number: 12275607
• Product Code: JDI
• UDI-Device Identifier: 10603295276616
• UDI-Public: 10603295276616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 152190056
• Device Lot Number: 1091334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2003
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANCELLOUS BONE SCREW 6.5X25MM; CANCELLOUS BONE SCREW 6.5X30MM; DURALOC 1200 SERIES 48MM OD; ENDURON 10D 48OD X 26ID; UNK HIP FEMORAL STEM AML
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown