MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-54-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter 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
Doi: (b)(6) 2004: patient received a primary left tha to treat advanced avascular necrosis.The patient received a pinnacle/corail metal-on-metal hip.The procedure was completed without complications.Dor: (b)(6) 2019: patient received a left hip revision to treat dull pain and mri identified metal-on metal reaction.Preoperative testing revealed elevated serum blood heavy metal levels.Upon entering the joint, the surgeon identified and excised black stained synovium.There was no wear or reported defects of the revised femoral head.There was minimal corrosion of the femoral stem trunnion.The corrosion was cleaned, and the well-fixed stem was retained.There was noted corrosion on the metal liner, and it was revised.The well-fixed cup was retained.The patient was revised with a depuy poly liner and ceramic femoral head.The procedure was completed without complications.Doi: (b)(6) 2004.Dor: (b)(6) 2019.Left 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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: ARTICULEZE M HEAD 36MM +12
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13802500
• Report Number: 1818910-2022-04897
• Device Sequence Number: 14426199
• Product Code: JDI
• UDI-Device Identifier: 10603295033974
• UDI-Public: 10603295033974
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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 Model Number: 1365-54-000
• Device Catalogue Number: 136554000
• Device Lot Number: 1130644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2003
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; CORAIL HA W/O COLLAR S12 150MM; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male