FDA Adverse Event
Injury
Summary report: N
DELTA CER HEAD 12/14 36MM +1.5
MDR report key: 1770256
·
Received July 21, 2010
Report
- Report Number
- 1818910-2010-04750
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- June 23, 2010
- Report Date
- June 23, 2010
- Manufacturer
- DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- LZO
- PMA / PMN Number
- K031803
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA CER HEAD 12/14 36MM +1.5 | 87LZO | LZO | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 3063684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |