MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-21 for TOTAL KNEE 1900 manufactured by Ossur Americas.
[136756051]
The knee locked as the patient was stepping on defective flooring in the bathroom of her apartment. The failure was noticed suddenly. The patient suffered a fractured ankle as a result of the fall. Patient now has permanent pins in her ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001836248-2019-00002 |
| MDR Report Key | 8358046 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-21 |
| Date of Report | 2019-05-23 |
| Date of Event | 2017-07-03 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL KNEE 1900 |
| Generic Name | PROSTHETIC KNEE |
| Product Code | ISY |
| Date Received | 2019-02-21 |
| Model Number | 1900 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 910 BURSTEIN DR. ALBION MI 49224 US 49224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-02-21 |