MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-09-30 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE 00588005017 manufactured by Zimmer, Inc..
[16032786]
It is reported that the device was implanted in 2007 and that the patient was revised in 2009, due to a broken hinge post. Surgeon states that patient is an active male who works as a forklift operator.
Patient Sequence No: 1, Text Type: D, B5
[16114701]
Evaluation summary: the device was in-vivo almost 2 years. Surgeon states that the patient is a male (height and weight unk) with a high activity level who works as a forklift operator. Surgeon further states that "in the first surgery... In 2007 that the patient had a tremendous amount of bone loss. " fracture of the hinge post extension occurred just beneath the threads. Sem of the returned hinge post extension showed mechanical deformation on the fracture surface which appear to have been caused by fatigue. Eds analysis shows peaks in the spectrum typical of wrought cocrmo alloy indicating no foreign materials were present. The fracture in the hinge post (which was not returned for evaluation) occurred perpendicular to the threaded portion of the component on the medial side. Review of the attached x-rays indicates that the bone quality is very poor. The explanted femoral component contains a large amount of bone cement. With inadequate bone stock due to the "tremendous amount of bone loss available to align the femoral implant, achieving proper alignment would have been difficult. The returned x-rays show a misalignment of the femoral and tibial components of about 16 degrees valgus. Misalignment of the implant can cause early failure of the devices due to the moment that is created on the hinge post extension. This added moment could cause a fracture of the device similar to the one returned for analysis. The probable contributors to the fracture are: tremendous amount of bone loss; component misalignment; and the patient activity level and build. However, a definitive root cause cannot be ascertained at this time. Evaluation: 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 | 1822565-2009-01024 |
| MDR Report Key | 1488929 |
| Report Source | 05,08 |
| Date Received | 2009-09-30 |
| Date of Report | 2009-08-04 |
| Date of Event | 2009-08-04 |
| Date Mfgr Received | 2009-08-31 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2009-10-06 |
| 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 |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-09-30 |
| Returned To Mfg | 2009-08-31 |
| Model Number | NA |
| Catalog Number | 00588005017 |
| Lot Number | 60612638 |
| ID Number | NA |
| Device Expiration Date | 2011-12-31 |
| 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 | 2009-09-30 |