MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for ZIMMER VIVACIT-E ELEVATED LINER 00885201136 manufactured by Zimmer Inc.
[38314156]
(b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[38314157]
It is reported that upon opening the implant, the scrub technician noticed a hair attached to the surface of the liner.
Patient Sequence No: 1, Text Type: D, B5
[65484317]
A poly liner and packaging content was returned for review. As returned, the fiber that is shown in the photo provided by the complainant was missing. The device history record (dhr) review shows no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event. This device is used for treatment. This event was found by a scrub tech prior to implantation; therefore, there was no patient risk. A complaint history search found there are no additional complaints for the product part/lot combination involved. A stock investigation was attempted; however, the remainder of the lot was fully distributed with no additional reported observations. Since the hair was found on the package after opening, the root cause cannot be definitively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00300 |
| MDR Report Key | 5439421 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-01-22 |
| Date of Event | 2016-01-22 |
| Date Mfgr Received | 2016-01-09 |
| Device Manufacturer Date | 2015-03-03 |
| Date Added to Maude | 2016-02-16 |
| 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 | ZIMMER VIVACIT-E ELEVATED LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-02-16 |
| Returned To Mfg | 2016-01-26 |
| Catalog Number | 00885201136 |
| Lot Number | 62954534 |
| 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 | 2016-02-16 |