MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for UNITED ORTHOPEDIC CORPORATION U2TOTAL KNEE SYSTEM 2403-3040 manufactured by United Orthopedic Corporation.
[24026132]
Pt scheduled for left total knee replacement. An expired product dated (02/2015 left xpe patella) was implanted. This product was brought to the organization on the day of surgery by united orthopedic corporation service rep for this procedure. Implant availability was confirmed prior to the start of the procedure during the "time out" process. The expired implant discovery did not occur until the knee had been sized. At that point, the surgeon requested the appropriate size based on the trial process. The rep passed the requested size to the rn circulator. The circulator visualized for integrity and expiration. At that point, she informed the rep the implant was expired. He brought a second implant which too was expired. The rep did not have another implant specific to the size the surgeon requested. The surgeon was informed. The surgeon requested to use the expired implant "due to the nature of the case. " the surgeon did inform the pt of the situation. The sales rep noted his company had informed him of impending expiration dates of products as early as 12/2014, but, he failed to remove implants prior to bringing products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5020846 |
| MDR Report Key | 5020846 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-07-20 |
| Date Facility Aware | 2015-07-20 |
| Report Date | 2015-07-29 |
| Date Added to Maude | 2015-08-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNITED ORTHOPEDIC CORPORATION |
| Generic Name | PATELLA 32 MM DIAMETER |
| Product Code | HTG |
| Date Received | 2015-08-05 |
| Model Number | U2TOTAL KNEE SYSTEM |
| Catalog Number | 2403-3040 |
| Lot Number | 09L120Q |
| Device Expiration Date | 2015-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED ORTHOPEDIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-05 |