MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-12-23 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P 00588003017 manufactured by Zimmer, Inc..
[20935895]
It is reported that the devices were implanted in 2009 and that the pt was revised the following month, due to infection. Upon revising the surface, the surgeon had to replace the femoral svc parts due to the hinge parts being welded together. Once the surface was removed, it was noticed that there was a shard piece of metal imbedded in the surface.
Patient Sequence No: 1, Text Type: D, B5
[21193343]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2009-01250 |
| MDR Report Key | 1567081 |
| Report Source | 05,08 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-09-21 |
| Date Mfgr Received | 2009-12-04 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-01-05 |
| 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 PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-12-23 |
| Returned To Mfg | 2009-12-04 |
| Model Number | NA |
| Catalog Number | 00588003017 |
| Lot Number | 61145556 |
| ID Number | NA |
| Device Expiration Date | 2013-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-12-23 |