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 2016-03-04 for CONTINUUM VIVACIT-E POLY LINER 00885101032 manufactured by Zimmer Inc.
[39686843]
Information was received from a distributor who is not required to complete form 3500a. (b)(4). Other device used: catalog #00784803201, m/l taper kinectiv neck, lot #62860671. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[39686844]
It is reported the patient was revised for an unknown reason. The liner and neck were replaced.
Patient Sequence No: 1, Text Type: D, B5
[40955635]
Other device used: catalog #00875705201 , continuum shell with cluster holes, lot #62831141. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55218576]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55218577]
It is reported the patient was revised due to pain following a hip arthroplasty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-00560 |
| MDR Report Key | 5480650 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-03-04 |
| Date of Report | 2018-03-16 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2014-09-29 |
| Date Added to Maude | 2016-03-04 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM VIVACIT-E POLY LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-03-04 |
| Catalog Number | 00885101032 |
| Lot Number | 62813463 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2016-03-04 |