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 2008-09-18 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001501 manufactured by Zimmer, Inc..
[955330]
It is reported that the device was implanted in late 2007. The device was revised approx 2 1/2 weeks post-op, due to deep infection. The revision surgery occurred in early 2008. The site reports that this event is not being related to the original implanted device.
Patient Sequence No: 1, Text Type: D, B5
[8262884]
Eval summary - the sterilization process for this device was validated in accordance with fda regulations and iso standards to a sterility assurance level of 10-6 or better. Therefore, it is unlikely that the specified device caused or contributed to the pt infection. Cause cannot be definitively determined. No product was returned. Review of the device history records was also not possible as the product and/or lot numbers required for retrieval were unavailable. 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 available info, the need for corrective action is not indicated. Should additional info be received, the complaint will be reopened. Zimmer considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00608 |
| MDR Report Key | 1165684 |
| Report Source | 02,05,07 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-09-08 |
| Date of Event | 2008-01-07 |
| Date Facility Aware | 2008-09-08 |
| Report Date | 2008-09-08 |
| Date Mfgr Received | 2008-09-08 |
| Date Added to Maude | 2008-09-24 |
| 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 | ANN RECKTENWALL |
| 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 FEMORAL COMPONENT |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-09-18 |
| Model Number | NA |
| Catalog Number | 00588001501 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 17 DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1195019 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-09-18 |