MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for VIVACIT-E HIGHLY CROSSLINKED LINER ELEVATED 00885200932 manufactured by Zimmer Inc.
[42528166]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[42528167]
It is reported that the liner would not seat into the continuum shell.
Patient Sequence No: 1, Text Type: D, B5
[44571884]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00996 |
| MDR Report Key | 5564468 |
| Date Received | 2016-04-08 |
| Date of Report | 2018-03-02 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2016-04-08 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVACIT-E HIGHLY CROSSLINKED LINER ELEVATED |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-04-08 |
| Returned To Mfg | 2016-04-11 |
| Catalog Number | 00885200932 |
| Lot Number | 62990622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-08 |