N
Patient 1
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.
MAUDE MDR 8934722
- MDR report key
- 8934722
- Report number
- 0001825034-2019-03792
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-01
- Date received
- 2019-08-27
- 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. CHRISTINA ARNT
- Address
- 56 E. BELL DR. WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIOCUE STD KIT ACD-A W/BD | BIOLOGICS, INSTRUMENT | ZIMMER BIOMET, INC. | JQC | 800-0613A | 702282 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-08-27 | 0 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING THE PROCEDURE, THE INCORRECT SIZE OF SEPARATOR WAS USED AND THE BLOOD WAS UNABLE TO BE SEPARATED. THE PATIENT WILL UNDERGO AN ADDITIONAL SURGERY TO FINISH THE PROCEDURE.