MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2009-07-10 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001602 manufactured by Zimmer, Inc..
[1100314]
It is reported that the hinge on the femoral component broke and was repaired in 2008. The device was not revised; only the hinge was replaced using a hinge servicing kit. Implant date is unknown.
Patient Sequence No: 1, Text Type: D, B5
[8436774]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2009-00764 |
| MDR Report Key | 1413400 |
| Report Source | 05,07,08 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-06-09 |
| Date of Event | 2008-05-01 |
| Date Mfgr Received | 2009-06-10 |
| Date Added to Maude | 2009-07-16 |
| 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 | PO 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 FEMORAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-07-10 |
| Model Number | NA |
| Catalog Number | 00588001602 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | PO BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-07-10 |