D
Patient 1
PATIENT WAS REVISED TO ADDRESS PAIN.
MAUDE MDR 3087212
- MDR report key
- 3087212
- Report number
- 1818910-2013-16359
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-04-22
- Date received
- 2013-05-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- STACEY TRICK
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Phone
- 574-574-5743
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY SIGMA SZ 2.5 CR FEMUR | FEMORAL KNEE PROSTHESIS | 1818910 DEPUY ORTHOPAEDICS, INC. | HSA | UNK-KNEE | UNKNOWN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-05-01 | 0 | 1. R |
Event Narratives#
N
Patient 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
N
Patient 1
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT CODE AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE: HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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.