D
Patient 1
IT WAS REPORTED THAT PATIENT UNDERWENT A PATIENT-MATCHED ANKLE PROCEDURE ON (B)(6) 1997. SUBSEQUENTLY, PATIENT UNDERWENT REVISION ON (B)(6) 1999, DUE TO COLLAPSE OF THE TALUS. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.
MAUDE MDR 2600415
- MDR report key
- 2600415
- Report number
- 0001825034-2012-00773
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-12-07
- Date received
- 2012-06-06
- 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
- MS. ANGELA DICKSON
- 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 | ANKLE TIB BEARING 7MM | PROSTHESIS, KNEE | BIOMET ORTHOPEDICS | BSN | N/A | PM550902 | 339900 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-06-06 | 0 | 1. H; 2. R |
Event Narratives#
N
Patient 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS AND A SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC IMPLANTS". THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00769 / 00773).