MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-22 for PALACOS N/A 66022663 manufactured by Zimmer Surgical, Inc..
[103226596]
This event has been recorded by zimmer biomet under (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.
Patient Sequence No: 1, Text Type: N, H10
[103226597]
It was reported that during a knee surgery, the staff reported that when they opened the palacos bag, the bag tears and it becomes unsterile. They had to open a new one. There was harm reported from the customer but additional information has not been received on it. No delay was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2018-00259 |
| MDR Report Key | 7363021 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-22 |
| Date of Report | 2018-08-13 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-03-22 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALACOS |
| Product Code | JDZ |
| Date Received | 2018-03-22 |
| Model Number | N/A |
| Catalog Number | 66022663 |
| Lot Number | 802114411 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |