MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-07-02 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P 00588006014 manufactured by Zimmer, Inc..
[1086558]
It is reported that pt was being revised due to infection. During surgery the drivers were unsuccessful in removing the articular surface. Articular surface was not exchanged.
Patient Sequence No: 1, Text Type: D, B5
[8435642]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2009-00707 |
| MDR Report Key | 1412477 |
| Report Source | 01,05,08 |
| Date Received | 2009-07-02 |
| Date of Report | 2009-05-07 |
| Date of Event | 2009-05-05 |
| Date Mfgr Received | 2009-06-05 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2009-07-15 |
| 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 | BRIAN FIEDLER |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P |
| Generic Name | KNEE IMPLANT |
| Product Code | HRZ |
| Date Received | 2009-07-02 |
| Model Number | NA |
| Catalog Number | 00588006014 |
| Lot Number | 60641234 |
| ID Number | NA |
| Device Expiration Date | 2012-02-28 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Required No Informationntervention | 2009-07-02 |