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 POLYCENTRIC EBS KNEE JOINT K/D 3R60=KD manufactured by Otto Bock Healthcare Gmbh.
[188112851]
The complaint notification associated with this device described that one screw in the knee joint is loose. The user did not fall, no serious injuries were sustained as a result of the failure and no medical treatment was required. The evaluation of this specific device was conducted at the manufacturer's after sales service center on january 10th, 2018. After evaluation we found that all bolts including the upper posterior section of the knee joint where loose. An exact reason for the loosening of the bolt could not be determined. In this specific case the failure did not lead to a fall and/or serious injury, but it could cause or contribute to a serious injury if it were to recur. Therefore, we report this failure according to guidance for industry and fda staff on "mdr for manufacturers" chapter 2. 15.
Patient Sequence No: 1, Text Type: N, H10
[188112852]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2018-00053 |
| MDR Report Key | 9817124 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2017-11-17 |
| 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 | MODULAR POLYCENTRIC EBS KNEE JOINT K/D |
| Generic Name | MODULAR POLYCENTRIC EBS KNEE JOINT K/D |
| Product Code | ISY |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2018-01-02 |
| Model Number | 3R60=KD |
| Catalog Number | 3R60=KD |
| 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 |