FDA Adverse Event
Injury
Summary report: N
PINNACLE SECTOR II CUP 50MM
MDR report key: 2011283
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-02539
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K000306
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS LOOSENING OF THE CUP, WHICH HAD ALSO MOVED FROM ITS ORIGINAL POSITION. OSTEOLYSIS WAS ALSO REPORTED, AND THE PT HAD ELEVATED CHROMIUM LEVELS, AS WELL AS METAL DEBRIS IN SOFT TISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE SECTOR II CUP 50MM | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | B76G41000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |