MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for AQUA KNEE 3WR95 manufactured by Otto Bock Healthcare Gmbh.
[182992405]
Based on the information provided the patient failed to lock the knee and fell. No complaint against the device. The end-user admittedly reported failing to manually lock the knee when standing up to change positions during a family photo session. This is a new user and this is her first prosthesis. The use error has led to a serious injuries that required surgical intervention. In the instruction for use it is stated how to handle the locking function and that there is a risk when failing the locking function. The mistake made by the person who has used the device was the sole cause of the incident. Therefore, reporting to the authorities would be required at this time, based on the available information. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182992406]
Pt was taking family photos, was in a sitting position, when she stood up to move positions, patient failed to manually lock the knee, fell over and broke her femur bone. Surgery due to incident: pt had emergency surgery to reinforce femur with a titanium rod.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2017-00052 |
| MDR Report Key | 9817114 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2015-10-07 |
| Date Added to Maude | 2020-03-11 |
| 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 | MR. DOMINIK SCHMIDT |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal | 37115 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE GMBH |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 37115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUA KNEE |
| Generic Name | AQUA KNEE |
| Product Code | ISY |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2017-12-11 |
| Model Number | 3WR95 |
| Catalog Number | 3WR95 |
| Lot Number | 0001201240 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE GMBH |
| Manufacturer Address | MAX-NAEDER-STR. 15 DUDERSTADT, 37115 GM 37115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-11 |