MAUDE Adverse Event Report: DEPUY PINNACLE SECTOR 2 ACETABULAR CUP&ULTRAMET METAL ACEBABULAR LINER (METAL ON METAL; FEMORAL HEAD

Model Number 1365-53-000 SIZE 36MM+8.5 12/14

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 09/22/2015

Event Type  Injury  

Event Description

Failed right total hip arthroplasty secondary to adverse reaction to metal debris and pseudotumor.

• Brand Name: PINNACLE SECTOR 2 ACETABULAR CUP&ULTRAMET METAL ACEBABULAR LINER (METAL ON METAL
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5201372
• MDR Text Key: 30509385
• Report Number: MW5057662
• Device Sequence Number: 3
• Product Code: KXA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1365-53-000 SIZE 36MM+8.5 12/14
• Device Lot Number: 1187141
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 79 YR