MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-27 for FEMORAL COMPONENTS, INTRACONDYLAR LINK? MEGASYSTEM-C, SMALL, RIGHT 15-8521/26 manufactured by Waldemar Link Gmbh & Co. Kg.
[188265674]
It was reported that a disconnection of the femoral component from the stem occurred postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004371426-2020-00003 |
| MDR Report Key | 9887420 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2020-03-27 |
| 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 | REBEKKA WINTERHOFF |
| Manufacturer Street | BARKHAUSENWEG 10 |
| Manufacturer City | HAMBURG, 22339 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22339 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL COMPONENTS, INTRACONDYLAR LINK? MEGASYSTEM-C, SMALL, RIGHT |
| Generic Name | UNCOATED KNEE FEMUR PROSTHESIS |
| Product Code | KRO |
| Date Received | 2020-03-27 |
| Catalog Number | 15-8521/26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-03-27 |