N
Patient 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
MAUDE MDR 5116216
- MDR report key
- 5116216
- Report number
- 1822565-2015-01999
- Event key
- 0
- Event type
- 3
- Date received
- 2015-10-01
- 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
- KEVIN ESCAPULE
- 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 | UNKNOWN ZIMMER REVERSE SHOULDER | SHOULDER PROSTHESIS | ZIMMER INC | KWR | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-01 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TWO-STAGE REVISION FOR INFECTION WITH THE SECOND STAGE OCCURRING ON (B)(6) 2015.
N
Patient 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
N
Patient 1
OPERATIVE NOTES WERE REQUESTED HOWEVER NONE PROVIDED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THESE PRODUCTS WERE USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THESE PRODUCTS COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. IT COULD NOT BE CONFIRMED IF THE DEVICES ARE AN APPROVED AND COMPATIBLE COMBINATION. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.