FDA Adverse Event
Malfunction
Summary report: N
PINNACLE 300 ACET CUP 54MM
MDR report key: 1053644
·
Received May 27, 2008
Report
- Report Number
- 1818910-2008-02000
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- P070026
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
DURING SURGERY, THE LINER GOT CROSSED WITH THE SHELL CAUSING A DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE 300 ACET CUP 54MM | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | CA9GV1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |