FDA Adverse Event
Injury
Summary report: N
MBT POR KEEL TIB TRAY SZ3
MDR report key: 1213954
·
Received October 27, 2008
Report
- Report Number
- 1818910-2008-04648
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 1, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- NJL
- PMA / PMN Number
- P830055/S095
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED DEVICE LOOSENING. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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
THE PT WAS REVISED BECAUSE OF LOOSENING OF THE TIBIAL TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MBT POR KEEL TIB TRAY SZ3 | 87NJL | NJL | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |