MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-10-12 for N-K II ALL POLY CONGRUENT TIBIA 635004009 manufactured by Zimmer, Inc..
[20230813]
It is reported that upon opening sterile package, implant was discolored/yellow. Surgeon was concerned about implant color and switched knee systems.
Patient Sequence No: 1, Text Type: D, B5
[20538299]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2012-02078 |
| MDR Report Key | 2793679 |
| Report Source | 05,08 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-09-10 |
| Date Mfgr Received | 2012-09-12 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-11-15 |
| 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 | KEVIN ESCAPULE |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N-K II ALL POLY CONGRUENT TIBIA |
| Generic Name | KNEE PROSTHESIS |
| Product Code | KRN |
| Date Received | 2012-10-12 |
| Returned To Mfg | 2012-09-17 |
| Catalog Number | 635004009 |
| Lot Number | 61899915 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | PO BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-12 |