MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for ROTATING HINGED TOTAL KNEE PROSTHESIS 15-8022/11U manufactured by Waldemar Link Gmbh & Co. Kg.
[138508212]
Patient Sequence No: 1, Text Type: N, H10
[138508213]
Per conversation with the representative in the room, patient presented to surgeon with a dislocated endo knee. She didn't know how it happened and it had been that way "for a while". Dr. Was able to expose the knee, remove the old tibial plateau, reduce the knee and insert a new tibial plateau. Could not tell the mode of dislocation. The femur had pulled off the tibia, but the plastic insert was still on the tibia. It looked like the female bushing of the femur had worn through the tibial plateau plastic. Surgeon was happy with the result. Note: this is not a new event. The manufacturer notified fda under mdr # 3004371426-2015-00004.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006721341-2019-00003 |
| MDR Report Key | 8410051 |
| Date Received | 2019-03-11 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-16 |
| Date Facility Aware | 2015-09-18 |
| Report Date | 2015-10-14 |
| Date Reported to FDA | 2015-10-14 |
| Date Reported to Mfgr | 2015-09-18 |
| Date Added to Maude | 2019-03-11 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTATING HINGED TOTAL KNEE PROSTHESIS |
| Generic Name | ROTATING HINGED TOTAL KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2019-03-11 |
| Model Number | 15-8022/11U |
| Lot Number | 020413/0597 |
| Device Expiration Date | 2007-07-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALDEMAR LINK GMBH & CO. KG |
| Manufacturer Address | BARKHAUSENWEG 10 HAMBURG, 22339 GM 22339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-11 |