MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-12-12 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE 00588003020 manufactured by Zimmer, Inc..
[19281525]
It is reported that the device was implanted in 2008 and was revised seven months later, due to the hinge post loosening (unthreading) from hinge assembly causing knee to dislocate and poly to dislodge.
Patient Sequence No: 1, Text Type: D, B5
[19442542]
Evaluation summary - the loosening of the hinge post extension can result if it is initially under torqued. Tightening of the hinge post extension to the required torque of 130 in-lbs is critical for the proper functioning of the parts. It is unknown if the hinge post extension was initially torqued to the required 130 in-lbs. The parts were not returned and x-rays were not provided for evaluation. The cause of the loosening of the hinge post extension could be definitively determined based on the available information. 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 | 1822565-2008-00904 |
| MDR Report Key | 1262774 |
| Report Source | 05,08 |
| Date Received | 2008-12-12 |
| Date of Report | 2008-11-11 |
| Date of Event | 2008-11-10 |
| Date Facility Aware | 2008-11-11 |
| Report Date | 2008-11-11 |
| Date Mfgr Received | 2008-11-12 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-01-21 |
| 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 | 3 |
| Event Location | 3 |
| 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 ARTICULAR SURFACE WITH HINGE |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-12-12 |
| Model Number | NA |
| Catalog Number | 00588003020 |
| Lot Number | 60863610 |
| ID Number | NA |
| Device Expiration Date | 2012-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| 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 | 2008-12-12 |