N
Patient 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
MAUDE MDR 5959821
- MDR report key
- 5959821
- Report number
- 0001822565-2016-03285
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-10-15
- Date received
- 2016-09-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CARRIE SCHNEIDER
- Address
- P.O. BOX 708 WARSAW IN 46581 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER | HIP PROSTHESIS | ZIMMER, INC. | OQI | 00885201236 | 62720387 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-19 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO INFECTION.
N
Patient 1
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM 00784301308, REVISION FEMORAL STEM, LOT # 62509389; ITEM 00875705601, SHELL WITH CLUSTER HOLES, LOT # UNKNOWN. UNKNOWN COCR CABLES WITH TI CRIMP COCR CABLES UNKNOWN BIOLOX CERAMIC HEAD. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF STERILIZATION CERTIFICATE CONFIRMED THE DEVICE WAS STERILIZED IN ACCORDANCE WITH PROCEDURE AND REGULATIONS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
D
Patient 1
ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATE THE HEAD AND LINER WERE REVISED AND IRRIGATION AND DEBRIDEMENT. DURINIG THE PROCEDURE, SEROSANGUINOUS FLUID WAS FOUND DOWN TO FASCIA WHEN IRRIGATED.