MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-10-11 for VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER 00885101436 manufactured by Zimmer, Inc..
[56966980]
This report will be amended when our investigation is complete. Received, not yet evaluated.
Patient Sequence No: 1, Text Type: N, H10
[56966981]
It is reported that upon opening the implant debris was found in the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-03652 |
| MDR Report Key | 6016646 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-10-11 |
| Date of Report | 2018-05-01 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2015-04-28 |
| Date Added to Maude | 2016-10-11 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2016-10-11 |
| Returned To Mfg | 2016-09-15 |
| Catalog Number | 00885101436 |
| Lot Number | 63021245 |
| 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 | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-11 |