MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-12-11 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P 00588004020 manufactured by Zimmer, Inc..
[1012535]
It is reported that the device was implanted in 2008 and revised six months later due to when the patient got out of bed, her knee gave out causing her to fall. When the knee was opened, the insert was in place but, post was posterior to tibia and somehow came loose.
Patient Sequence No: 1, Text Type: D, B5
[8161441]
Evaluation summary: no product and x-rays were returned for evaluation. Upon revision surgery of the knee, it was found that the post was posterior to tibia and came loose. Also, it is reported that the 20mm thick articular surface was exchanged with a 26mm articular surface. Based on the provided information of a thicker articular surface being implanted during the revision surgery, it is likely that the knee was loose and unstable initially and caused the problem. Method/results - 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 | 1822565-2008-00900 |
| MDR Report Key | 1264064 |
| Report Source | 05,08 |
| Date Received | 2008-12-11 |
| Date of Report | 2008-11-11 |
| Date of Event | 2008-11-07 |
| Date Facility Aware | 2008-11-11 |
| Report Date | 2008-11-11 |
| Date Mfgr Received | 2008-11-11 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-01-26 |
| 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 | 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 P |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-12-11 |
| Model Number | NA |
| Catalog Number | 00588004020 |
| Lot Number | 60852915 |
| ID Number | NA |
| Device Expiration Date | 2012-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 MO |
| 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 | 2008-12-11 |