MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-12-19 for NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT 00588001402 manufactured by Zimmer, Inc.
[999639]
It is reported that the device was implanted in 2007, and that the pt was revised in 2008 due to pt pain, instability, and 20 degrees of hyperextension. Once the knee was exposed in the or, it was determined that the femoral hinge was broken in half at the threads for the hinge post extension. The articular surface was removed followed by the removal of the femoral component. When the femoral component was removed, the 16mm x 155mm nexgen stem extension that was attached to the femur remained in the femoral canal. After repeated attempts to remove the stem extension from the femur,the surgeon decided to leave to stem extension in the canal and fixate a new rhk femoral component to it.
Patient Sequence No: 1, Text Type: D, B5
[8165277]
Evaluation summary: it was reported that a revision of a rotating hinge knee system occurred due to pain, instability, and 20 degrees of hyperextension. The devices were implanted for 1. 5 years at time of revision, reportedly, the hinge post was fractured in half at the threads for the hinge post extension, which likely contributed to the excessive hyperextension since the stability in full extension relies upon the hinge post extension being held in place by the hinge post. The failure mode cannot be conclusively identified as the probable cause without return of the parts. Without return of the parts for evaluation, the cause of the hinge post fracture cannot be determined. Evaluation codes: method and 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 info be received, the complaint will be reopened, zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00937 |
| MDR Report Key | 1269131 |
| Report Source | 05,08 |
| Date Received | 2008-12-19 |
| Date of Report | 2008-11-14 |
| Date of Event | 2008-11-14 |
| Date Facility Aware | 2008-11-14 |
| Report Date | 2008-11-14 |
| Date Mfgr Received | 2008-11-24 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2008-12-29 |
| 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 | BRAIN 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 | 2008-12-19 |
| Model Number | NA |
| Catalog Number | 00588001402 |
| Lot Number | 60344326 |
| ID Number | NA |
| Device Expiration Date | 2015-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1327418 |
| Manufacturer | ZIMMER, INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 765810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-12-19 |