MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for CONTINUUM VIVACIT-E NEUTRAL POLY LINER 00885101436 manufactured by Zimmer Inc.
[34739526]
Information was received from a distributor who is not required to complete form 3500a. (b)(4). This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[34739527]
It is reported the surgeon was not able to seat the liner correctly without the patient dislocating; an alternate liner was used.
Patient Sequence No: 1, Text Type: D, B5
[40681770]
Visual inspection of the returned liner confirms that there are gouges near the rim of the liner and scratches on the rim consistent with removal of the liner. Dimensions were found conforming to print specifications where measured. Review of the device history record did not find any deviations or anomalies. This device is used for treatment. Product history search revealed no additional complaints against the related part and lot combination. It is unknown what shell and head was used with the liner. A definite root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-02706 |
| MDR Report Key | 5315459 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2016-03-09 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2015-12-21 |
| 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 | CONTINUUM VIVACIT-E NEUTRAL POLY LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2015-12-21 |
| Returned To Mfg | 2015-11-30 |
| Catalog Number | 00885101436 |
| Lot Number | 63078437 |
| 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 | 2015-12-21 |