MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for GPSIII 60 W/ACDA JP 800-1013 manufactured by Zimmer Biomet, Inc..
[138425740]
(b)(4). (b)(6). 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. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[138425741]
It was reported the surgeon was trialing the gps iii. However, the blood was not separated properly and also the syringe did not work properly. There was no patient involvement as this did not occur during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-00996 |
| MDR Report Key | 8398390 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-07-19 |
| Date Added to Maude | 2019-03-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GPSIII 60 W/ACDA JP |
| Generic Name | BIOLOGICS, INSTRUMENT |
| Product Code | KSS |
| Date Received | 2019-03-07 |
| Catalog Number | 800-1013 |
| Lot Number | 801924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |