MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-10-17 for GPS III SINGLE KIT W/30ML ACDA N/A 800-1003A manufactured by Zimmer Biomet, Inc..
[90535256]
(b)(4). Complaint sample was evaluated and the reported event was not confirmed. Based on device history records, the product was made to print and correct materials. Product left conforming to print as there was no evidence that states otherwise. The gps kit had an opened sterile component as stated in the complaint. The seal on the item in question shows an initial perfect seal with no? Bird eggs? That would cause a seal to fail. The anticoagulant solution also has a needle mark on the container showing it has been used. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. There are warnings in the package insert that this type of event can occur and 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.
Patient Sequence No: 1, Text Type: N, H10
[90535257]
It was reported that during a total hip arthroplasty, the gps kit was opened and one of the sterile components was already opened. Another unit was used to complete the procedure without delay. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-08791 |
| MDR Report Key | 6954082 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date of Event | 2015-09-03 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2014-12-19 |
| Date Added to Maude | 2017-10-17 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GPS III SINGLE KIT W/30ML ACDA |
| Generic Name | BIOLOGICS |
| Product Code | KSS |
| Date Received | 2017-10-17 |
| Returned To Mfg | 2015-09-17 |
| Model Number | N/A |
| Catalog Number | 800-1003A |
| Lot Number | 402677 |
| ID Number | N/A |
| Device Expiration Date | 2016-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-17 |