MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05,07 report with the FDA on 2015-04-17 for UNKNOWN INSALL / BURSTEIN TIBIAL COMPONENT manufactured by Zimmer Inc.
[5719428]
It is reported that the patient was revised due to a loose tibial component and polyethylene wear at 15 years post - implant.
Patient Sequence No: 1, Text Type: D, B5
[13232869]
Information was received via published literature. Please reference literature at the following location: http://jbjs. Org/content/96/18/e159. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-00561 |
| MDR Report Key | 4709798 |
| Report Source | 03,05,07 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-03-17 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| Event Location | 0 |
| 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 | UNKNOWN INSALL / BURSTEIN TIBIAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HSA |
| Date Received | 2015-04-17 |
| 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 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-17 |