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 EBS KNEE JOINT 3R60 manufactured by Otto Bock Healthcare Gmbh.
[188111933]
Customer stated that 4 bolts in the knee came loose, 2 bolts fell out completely. Client was involved in a motorcycle accident (b)(6) 2017. The customer indicated the device (3r60) was the cause of the fall. The client did seek medical attention and was hospitalized with multiple fractures. The evaluation of this specific device was conducted at the manufacturer's after sales service center on january 29th, 2018. Due to the time difference between the accident and the technical evaluation we can not identify the original failure which might have led to the fall. An exact reason for the loosening of the bolt could not be determined. We are also not able to assess the relationship between the event and the product based on the available information. 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
[188111934]
Knee joint was sent in for repair. Customer stated that 4 bolts in the knee came loose, 2 bolts fell out completely. Client was involved in a motorcycle accident (b)(6) 2017. The customer indicated the device (3r60) was the cause of the fall. The client did seek medical attention and was hospitalized with multiple fractures. The accident happened in (b)(6) 2017. The joint was not sent in for evaluation until (b)(6) 2018. We report out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2018-00054 |
| MDR Report Key | 9817132 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-07-15 |
| Date Mfgr Received | 2018-01-16 |
| 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 EBS KNEE JOINT |
| Generic Name | MODULAR EBS KNEE JOINT |
| Product Code | ISY |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2018-01-29 |
| 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 | 1. Hospitalization | 2020-03-11 |