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 2017-01-10 for VIVACIT-E VITAMN E HIGHLY CROSSLINKED POLY LINER N/A 00885101640 manufactured by Zimmer, Inc..
[64424461]
Current information is insufficient to permit a conclusion as to the cause of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64424462]
While opening the sterile packaging, a hair or fiber was found on the liner. No patient injury or delay in a procedure was reported as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-00028 |
| MDR Report Key | 6239204 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-01-10 |
| Date of Report | 2018-05-01 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2015-05-13 |
| Date Added to Maude | 2017-01-10 |
| 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVACIT-E VITAMN E HIGHLY CROSSLINKED POLY LINER |
| Generic Name | HIP PROSTHESIS |
| Product Code | OQI |
| Date Received | 2017-01-10 |
| Returned To Mfg | 2016-12-22 |
| Model Number | N/A |
| Catalog Number | 00885101640 |
| Lot Number | 63043509 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-01-10 |