FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE 300 ACETABULAR CUP
MDR report key: 3050112
·
Received March 15, 2013
Report
- Report Number
- MW5029663
- 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. HE RECEIVED THE DEPUY TOTAL HIP PINNACLE ACETABULAR CUP SZ MM 58, AND THE PINNACLE METAL INSERT 40MM ID X 58MM OD, IN (B)(6) 2010 HE BEGAN HAVING PAIN IN HIS RIGHT HIP MAKING IT DIFFICULT TO WALK OR PERFORM PHYSICAL ACTIVITY. HE ALSO HAS PAIN AND SORENESS WHEN HE LIFTS HIS RIGHT LEG. REASON FOR USE: SEVERE OSTEOARTHRITIS OF RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110328 | DEPUY PINNACLE 300 ACETABULAR CUP | METAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS, INC | 1217-03-058 | DH2CT1000 | |
| 110329 | DEPUY PINNACLE METAL INSERT | METAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS, INC | 1218-87-458 | 2928649 | |
| 110331 | DEPUY PINNACLE SECTOR 11 ACETABULAR CUP | METAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS, INC | 1217-22-058 | D1VF7100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |