MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-02-02 for NEXGEN COMPLETE KNEE SOLUTION POSTERIOR STABILIZED (PS) FEMO * 00598601502 manufactured by Zimmer, Inc..
[208213]
Approximately four years post op patient began to experience moderate discomfort. In 2000, x-rays revealed the tibia appeared to be loose. Revision surgery was performed in 2000.
Patient Sequence No: 1, Text Type: D, B5
[214826]
Approximately four years post op patient began to experience moderate discomfort. In 2000, x-rays revealed the tibia appeared to be loose. Revision surgery was performed in 2000.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2001-00003 |
| MDR Report Key | 314762 |
| Report Source | 06 |
| Date Received | 2001-02-02 |
| Date of Report | 2000-12-20 |
| Date of Event | 2000-12-15 |
| Date Facility Aware | 2000-12-20 |
| Report Date | 2000-12-20 |
| Date Mfgr Received | 2001-01-05 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 2001-02-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CONNIE MORGAN, MANAGER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 2193724269 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXGEN COMPLETE KNEE SOLUTION POSTERIOR STABILIZED (PS) FEMO |
| Generic Name | KNEE PROSTHESIS |
| Product Code | JWI |
| Date Received | 2001-02-02 |
| Returned To Mfg | 2001-01-05 |
| Model Number | * |
| Catalog Number | 00598601502 |
| Lot Number | 00397500 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 304408 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Baseline Brand Name | NEXGEN COMPLETE KNEE SOLUTION POSTERIOR STABILIZED (PS) FEMORAL COMPONENT |
| Baseline Generic Name | KNEE PROSTHESIS |
| Baseline Catalog No | 00598601502 |
| Baseline Device Family | NEXGEN KNEE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K933785 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-02-02 |