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 2009-04-16 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001602 manufactured by Zimmer, Inc..
[1048734]
It is reported that the device was implanted in 2007, and revised in 2009, due to the metal yoke breaking.
Patient Sequence No: 1, Text Type: D, B5
[8331534]
Evaluation summary: it is reported that the product was in vivo for approximately 1 year and 5 months before being revised, due to fracture of the hinge post. The hinge post, hinge post extension, articular surface, hinge pin, and poly box were all returned. The hinge post exhibits fracture at the threaded portion and signs of damage to the threads. Sem analysis indicated this likely occurred from fatigue loading, however, the origin of the fracture could not be determined. The hinge post extension exhibits damage to the threads. The articular surface exhibits significant damage and, sem analysis indicated the presence of third body co-cr-mo (cobalt chrome molybdenum) particles on the articular surface, likely from the damage hinge post. The poly box also shows signs of damage to the stop, typical of hyperextension. Hypertension of the knee could have contributed to the fatigue failure of the hinge post. The height and weight of the patient are unknown, as is the torque applied to the hinge post extension during implantation. X-rays were not provided, and the implant alignment is unknown. Based on the provided information a definitive cause of the hinge post fracture cannot be determined. Device history records indicate all components were manufactured and inspected to specification. Scanning electron microscopy (sem) analysis / energy dispersive spectroscopy (eds) analysis was performed. No manufacturing abnormalities could be detected by either method.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2009-00441 |
| MDR Report Key | 1365076 |
| Report Source | 01,05,08 |
| Date Received | 2009-04-16 |
| Date of Report | 2009-03-17 |
| Date of Event | 2009-02-03 |
| Date Mfgr Received | 2009-03-17 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2009-04-23 |
| 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 FEMORAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-04-16 |
| Returned To Mfg | 2009-03-30 |
| Model Number | NA |
| Catalog Number | 00588001602 |
| Lot Number | 60533841 |
| ID Number | NA |
| Device Expiration Date | 2012-01-30 |
| 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 | 2009-04-16 |