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 2009-05-01 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE 00588006026 manufactured by Zimmer, Inc..
[1126390]
It is reported that the device was implanted in 2008, and that the patient was revised in 2009, due to the device breaking.
Patient Sequence No: 1, Text Type: D, B5
[8390500]
Evaluation summary: no product was returned for evaluation. From the returned photographs it appears that the hinge post extension and the hinge post both fractured near the threads due to fatigue. However, the cause of the fatigue loading is unknown. X-rays that were provided indicate that the patient presented with an anterior dislocation of the femur relative to the articular surface. This resulted from the lack of stability provided by the fractured hinge post extension. The implant alignment prior to failure cannot be determined from the x-rays. Without return of the parts and additional information such as implant alignment, analysis as to why the fractures occurred cannot be performed. Without additional information, the probable cause can not be determined. Evaluation: no product was returned. Review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2009-00516 |
| MDR Report Key | 1373427 |
| Report Source | 01,05,08 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-04-02 |
| Date of Event | 2009-03-31 |
| Date Mfgr Received | 2009-04-03 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2009-05-07 |
| 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 |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2009-05-01 |
| Model Number | NA |
| Catalog Number | 00588006026 |
| Lot Number | 60593980 |
| ID Number | NA |
| Device Expiration Date | 2011-11-30 |
| 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 | 2009-05-01 |