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	Naturally Worn (2988)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)
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
The primary surgery was performed on (b)(6) 2011 via tha at hyogo prefectural rehabilitation central hospital.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the head and the liner because the patient had a pain which was caused by pseudotumor.The reason of pseudotumor was thought to be mom.The stem was remained.The revision surgery was completed with 240 minutes delay.During the surgery, at the time of removal of the head, the surgeon found adhering substance which was considered to be metal debris.The surgeon requested to investigate the component of the adhering substance.The surgeon commented that the pseudotumor thought to be caused by mom.The explanted head, liner and remained stem will not be returned.The adhering substance which was found by the surgeon will be shipped to your site for investigation.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the depuy device associated with this report has not been returned.Pieces of debris taken from the patient were returned for examination.The material is tissue with trace cobalt and chromium debris, which would be consistent with tissue adjacent a metal-on-metal articulation and the typical wear debris generated from that articulation.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 ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10303055
• Report Number: 1818910-2020-16413
• Device Sequence Number: 754198
• Product Code: JDI
• UDI-Device Identifier: 10603295033073
• UDI-Public: 10603295033073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1365-11-500
• Device Catalogue Number: 136511500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: PINNACLE MTL INS NEUT28IDX46OD; SUMMIT POR TAPER SZ3 STD OFF; PINNACLE MTL INS NEUT28IDX46OD; SUMMIT POR TAPER SZ3 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 55