MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for MODULAR POLYCENTRIC EBS KNEE JOINT 3R60 manufactured by Otto Bock Healthcare Gmbh.
[188113882]
The visual evaluation showed that two of the upper bolts were loose. The patient fell but there were no serious injuries sustained as a result of the fall. No medical treatment was needed.
Patient Sequence No: 1, Text Type: N, H10
[188113923]
Knee joint was sent in for repair. According to information provided by the customer the bolts were loose. Patient fell, but there were no serious injuries sustained as a result of the fall. No medical treatment was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2018-00069 |
| MDR Report Key | 9817259 |
| Date Received | 2020-03-11 |
| Date of Report | 2018-07-03 |
| Date Mfgr Received | 2018-06-05 |
| Device Manufacturer Date | 2018-11-15 |
| 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 |
| 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 POLYCENTRIC EBS KNEE JOINT |
| Generic Name | MODULAR POLYCENTRIC EBS KNEE JOINT |
| Product Code | ISY |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2018-06-05 |
| Model Number | 3R60 |
| Catalog Number | 3R60 |
| 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 | 2020-03-11 |