FDA Adverse Event Injury Summary report: N

DEPUY PINNACLE SECTOR 11 ACETABULAR CUP

MDR report key: 3050108 · Received March 15, 2013

Report

Report Number
MW5029662
Event Type
Injury
Date Received
March 15, 2013
Manufacturer
DEPUY ORTHOPAEDICS, INC
Product Code
KWA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KY, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2005. HE RECEIVED THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP SZ MM 60, ULTAMET METAL-ON-METAL INSERT 06MMID X 60MMOD AND ARTICULAR/EZE METAL-ON-METAL FEMORAL HEAD. IN 2007, HE BEGAN HAVING PAIN IN HIS LEFT HIP WHICH MADE IT DIFFICULT TO WALK OR PERFORM PHYSICAL ACTIVITY. THIS PAIN IS GRADUALLY WORSENING, INTERFERING WITH HIS DAILY LIFE AND LIMITING HIS MOBILITY. REASON FOR USE: OSTEONECROSIS OF LEFT HIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
110942 DEPUY PINNACLE SECTOR 11 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-22-060 YW8C11000
110943 DEPUY ULTAMET METAL-ON-METAL INSERT METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC 121887360 1229284
110944 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD METAL-ON-METAL HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC 1365-53-000 1226764

Patients

Seq Age Sex Outcome Treatment
1