MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M 28MM 1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-11-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address pain and periprosthetic infection.Aspiration was negative for bacteria but also had 111 white blood cells.Intraoperatively, there was gross pus, bone loss, a deficiency of the posterior column related to the infection and fracture cracks in the proximal femur.Implants were removed and a non-articulating spacer construct of unknown manufacturer was placed.Revision notes on the second revision for removal of said spacer on (b)(6) 2018 indicate presence of a dark murky fluid consistent with metallosis as well as chalky, metallosis type debris.Doi: (b)(6) 2006; dor: (b)(6) 2018 (right hip).
Additional Manufacturer Narrative
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.H10 additional 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.Device history lot - null.Device history batch - null.Device history review - null.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: ARTICULEZE M 28MM 1.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9852878
• Report Number: 1818910-2020-08566
• Device Sequence Number: 16977119
• Product Code: JDI
• UDI-Device Identifier: 10603295033073
• UDI-Public: 10603295033073
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Expiration Date: 08/31/2009
• Device Model Number: 1365-11-500
• Device Catalogue Number: 136511500
• Device Lot Number: 1232621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUP 121722050/AA9M91000; LINER 121889150/1865880; SCREW 121720500/Z12C74000; STEM 157001080/Y5XEH1000
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR