MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2009-09-02 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001602 manufactured by Zimmer, Inc..
[19461206]
It is reported that the device was implanted in 2007, and revised in 2009, due to the hinge fracturing. The patient has gait abnormality and multiple sclerosis, which resulted in revision of the implants.
Patient Sequence No: 1, Text Type: D, B5
[19668176]
Evaluation summary: the device was in vivo for approximately 1 year and 8 months. No product or x-rays were returned for evaluation. A photograph was taken and returned for review and appears that the hinge post extension has fractured. The picture is relatively blurry, and further conclusions as to the cause of the fracture are unable to be made. It is unknown what contribution of the patient's history of multiple sclerosis and abnormal gait had to the fracture. Based on the available information a definitive root cause can not be ascertained at this time. Evaluation codes: 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 | 1822565-2009-00944 |
| MDR Report Key | 1464336 |
| Report Source | 02,05,07 |
| Date Received | 2009-09-02 |
| Date of Report | 2009-08-03 |
| Date of Event | 2009-07-20 |
| Date Mfgr Received | 2009-08-03 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2009-09-11 |
| 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 | 2009-09-02 |
| Model Number | NA |
| Catalog Number | 00588001602 |
| Lot Number | 60533841 |
| ID Number | NA |
| Device Expiration Date | 2012-01-31 |
| 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 | 2009-09-02 |