FDA Adverse Event
Injury
Summary report: N
PFC SIGMA/OV/DOME PAT 3PEG, 41
MDR report key: 2002387
·
Received February 18, 2011
Report
- Report Number
- 1818910-2011-02494
- Event Type
- Injury
- Date Received
- February 18, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K961685
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE REPORTED PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT REVISED FOR POLYETHYLENE WEAR OF INSERT AND FRACTURED PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA/OV/DOME PAT 3PEG, 41 | 87JWH | JWH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |