FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE 300 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT
MDR report key: 3050145
·
Received March 15, 2013
Report
- Report Number
- MW5029670
- 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
RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2009. SHE RECEIVED THE DEPUY TOTAL HIP PINNACLE 300 ACETABULAR CUP SZ MM 52, THE ARTICUL/EZE METAL ON METAL FEMORAL HEAD, 036MM +5 12/14 TAPER, AND THE PINNACLE METAL INSERT NEUTRAL 36MMID X 52MMOD. IN (B)(6) 2009, HER RIGHT HIP WAS DISLOCATED AND IN LATE 2009 SHE BEGAN HAVING PAIN IN HER RIGHT HIP WHICH RADIATES TO HER RIGHT LEG. SHE CAN NO LONGER BEND DOWN DUE TO THE CONTINUED DISLOCATION RISK. THESE SYMPTOMS ARE ONGOING. REASON FOR USE: OSTEOARTHRITIS OF RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110764 | DEPUY PINNACLE 300 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT | METAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS INC | 1217-03-052 | DY5B31000 | |
| 110765 | DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD | METAL-ON-METAL HIP IMPLANT | JDI | DEPUY ORTHOPAEDICS INC | 1365-52-000 | 2955157 | |
| 110766 | DEPUY PINNACLE METAL INSERT | METAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS INC | 1218-87-352 | 2921951 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |