N
Patient 1
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT DEVICE CODE = JQO.
MAUDE MDR 6639465
- MDR report key
- 6639465
- Report number
- 0001825034-2017-03847
- Event key
- 0
- Event type
- 3
- Date received
- 2017-06-14
- 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 | BIOMET BIOLOGICS COUNTERBALANCE | BIOMET BIOLOGICS | JQO | N/A | 800-0508 | 125033 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-14 | 0 | 1. H |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING A PROCEDURE UTILIZING A GPS KIT, THE COUNTER BALANCE WATER TUBE BROKE DURING CENTRIFUGATION. A NEW COUNTERBALANCE WAS PLACED IN THE CENTRIFUGE AND THE BLOOD WAS SPUN TO COMPLETE THE PROCEDURE, AFTER DELAYING PROCEDURE FOR FORTY-FIVE (45) MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
N
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO PATIENT INJURY NOR HARM. THE INITIAL REPORT WAS FILED IN ERROR AND SHOULD BE VOIDED. 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.