FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY 35 PATELLA
MDR report key: 2071572
·
Received April 15, 2011
Report
- Report Number
- 1818910-2011-06312
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 16, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN BASED ON THE PROVIDED INFORMATION. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY 35 PATELLA | TOTAL KNEE PROSTHESIS | JWH | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |