MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC+12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-64-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Hematoma (1884); Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to obtain the legal contact information.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
Medical records received.After review of medical records, it was reported that the patient fell sustaining the aforementioned periprosthetic hip fracture.Patient also had 3 previous dislocation event.The patient was then revised for right periprosthetic proximal femur fracture and metal on metal tha components with extensive metallosis and soft tissue necrosis.Operative notes indicate that a extensive hematoma was encounter.It was noted that no fascia present as there was a direct line from the hematoma into the joint hip.It appeared that there was extensive metallosis and soft tissue necrosis likely related to the metal on metal articulation.The posterior aspect of the greater trochanter was noted to be denuded of the soft tissue attachment.It was indicated that stem was stable and only the greater trochanter was fractured and fragmented.There was noted to be some metallosis along the trunnion.Doi: (b)(6) 2007.Dor: (b)(6) 2021.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.Device history lot a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

• Brand Name: 12/14 ARTICUL 44MM M SPEC+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
• MDR Report Key: 12088992
• Report Number: 1818910-2021-13839
• Device Sequence Number: 3464763
• Product Code: LPH
• UDI-Device Identifier: 10603295034155
• UDI-Public: 10603295034155
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• 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): 06/15/2021

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 Expiration Date: 06/30/2012
• Device Model Number: 1365-64-000
• Device Catalogue Number: 136564000
• Device Lot Number: 2415130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 12/14 ARTICUL 44MM M SPEC+12; CORAIL2 LAT COXA VARA SIZE 15; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 62MM; PINNACLE MTL INS NEUT44IDX62OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR