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 MODULAR KNEE JOINT WITH ROTARY HYDRAULIC 3R80 manufactured by Otto Bock Healthcare Gmbh.
[188112156]
Product and/or additional information not arrived until now although requested several times. No information provided by the customer if there were serious injuries sustained as a result of the failure. A specific investigation could not be conducted until now. The complaint cannot be reproduced at this time.
Patient Sequence No: 1, Text Type: N, H10
[188112157]
The lock lever fell into place while the patient (who is also the practitioner) was trying to clear a step. The locked knee did not allow him get this foot all the way over the step, he hit the step with his toes and fell. This did not completely solve the problem, the patient is now in the hospital due to a fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2018-00064 |
| MDR Report Key | 9817248 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2017-02-09 |
| 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, NIEDERSACHSEN 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 | MODULAR KNEE JOINT WITH ROTARY HYDRAULIC |
| Generic Name | MODULAR KNEE JOINT WITH ROTARY HYDRAULIC |
| Product Code | ISY |
| Date Received | 2020-03-11 |
| Model Number | 3R80 |
| Catalog Number | 3R80 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-11 |