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.
[188113501]
The visual evaluation showed that one of the upper bolts is missing and one were stripped. No fall or injury occurred due to this failure, but it could have led to patient injury.
Patient Sequence No: 1, Text Type: N, H10
[188113502]
Knee joint was sent in for repair. According to information provided by the customer the bolts were loose. No fall, no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2018-00066 |
| MDR Report Key | 9817258 |
| Date Received | 2020-03-11 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2017-03-21 |
| 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 | 2018-05-09 |
| 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 |