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 |