FDA Adverse Event
Injury
Summary report: N
SMARTSET GHV GENTAMICIN 40G
MDR report key: 1990822
·
Received February 8, 2011
Report
- Report Number
- 1818910-2011-01901
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- PMA / PMN Number
- K033563
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFO REQUIRED IN SEARCHING THE COMPLAINT DATABASE BY PRODUCT LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSET GHV GENTAMICIN 40G | 87LOD; 87MBB | LOD | DEPUY CMW | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |