FDA Adverse Event
Injury
Summary report: N
LCS TEX ROT PLAT TIB PLAT STD+
MDR report key: 1230487
·
Received January 17, 2008
Report
- Report Number
- 1818910-2007-00101
- Event Type
- Injury
- Date Received
- January 17, 2008
- Date of Event
- January 9, 2007
- Report Date
- January 9, 2007
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- NJL
- PMA / PMN Number
- P830055/R44
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL TRAY AND POLY WEAR ON THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCS TEX ROT PLAT TIB PLAT STD+ | 87NJL | NJL | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |