FDA Adverse Event
Injury
Summary report: N
DEPUY INT'L LTD
MDR report key: 1880895
·
Received October 22, 2010
Report
- Report Number
- MW5017845
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- April 1, 2010
- Report Date
- October 22, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAS BEEN IN AND OUT OF ER FOR THE LAST 3 YEARS. PT IS EXPERIENCING CHRONIC PAIN, BURNING DOWN LEFT LEG UP TO THIGH, LOSS OF RANGE OF MOTION, FOCUSSING PROBLEMS, NUMBNESS AND SUICIDAL IDEATION. PATELLA HAS ERODED AND IS REALLY GONE, PT HAS HAD WEIGHT GAIN AND IS NOT ABLE TO WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY INT'L LTD | BONE CEMENT 40 G | LOD | DEPUY INTERNATIONAL, LTD. | 1875428 | ||
| 2 | DEPUY INT'L LTD | BONE CEMENT 40G | LOD | DEPUY INTERNATIONAL, LTD. | 1921199 | ||
| 3 | DEPUY PFC SIGMA RPF | FEMORAL SIZE # 3 LT | JWH | DEPUY INTERNATIONAL, LTD. | ZB1DL4000 | ||
| 4 | DEPUY | CEMENTED KEEL TRAY # 35Z | JWH | DEPUY INTERNATIONAL, LTD. | 283EG1000 | ||
| 5 | DEPUY | TIBIAL INSERT SZ # 3 | JWH | DEPUY INTERNATIONAL, LTD. | Y5XP24000 | ||
| 6 | DEPUY | OVAL DOME PATELLA 3-PEG | JWH | DEPUY INTERNATIONAL, LTD. | 2064990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |