MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 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	Foreign Body Reaction (1868); No Code Available (3191)
Date of Event	10/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.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
After review of medical records, the patient was revised for mechanical failure, metal on metal, right tha.Operative note reported that there was black staining of the soft tissue inside the pseudocapsule.Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.
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.

• Brand Name: ARTICULEZE M 28MM 1.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10216432
• Report Number: 1818910-2020-14778
• Device Sequence Number: 16745340
• Product Code: JDI
• UDI-Device Identifier: 10603295033073
• UDI-Public: 10603295033073
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 10/30/2009
• Device Model Number: 1365-11-500
• Device Catalogue Number: 136511500
• Device Lot Number: 1808616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: ARTICULEZE M 28MM 1.5; PINNACLE MTL INS NEUT28IDX48OD; ARTICULEZE M 28MM 1.5; PINNACLE MTL INS NEUT28IDX48OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR