N
Patient 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
MAUDE MDR 5056011
- MDR report key
- 5056011
- Report number
- 0001825034-2015-03867
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-17
- Date received
- 2015-09-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. MEGAN HAAS
- Address
- 56 E. BELL DRIVE WARSAW IN 46582 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 | SSI INSERTER | INSTRUMENT, HIP | BIOMET ORTHOPEDICS | LKD | N/A | SSI002707 | RDWO41557 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-04 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, A G7 SSI CURVED IMPACTOR FRACTURED. A PIECE OF THE FRACTURED INSERTER FELL IN THE PATIENT AND WAS REMOVED. THERE WAS A SLIGHT DELAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.