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 2016-04-26 for CONTINUUM, TRILOGY IT, ALLOFIT IT POLY LINER 00875101740 manufactured by Zimmer, Inc. - Building 5.
[43673486]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[43673487]
It is reported the liner would not lock into the cup during surgery. An alternate liner was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-01313 |
| MDR Report Key | 5608693 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-04-26 |
| Date of Report | 2017-11-28 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-04-26 |
| 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 | MR. KEVIN ESCAPULE |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. - BUILDING 5 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUUM, TRILOGY IT, ALLOFIT IT POLY LINER |
| Generic Name | OQI |
| Product Code | OQI |
| Date Received | 2016-04-26 |
| Returned To Mfg | 2016-04-06 |
| Catalog Number | 00875101740 |
| Lot Number | 63180082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. - BUILDING 5 |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-26 |