MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-03 for MODULAR POLYCENTRIC EBS KNEE JOINT 3R60 manufactured by Ottobock Se & Co Kgaa.
[188106375]
While walking the patient noticed play and a "squishy" feel in the prosthetic knee joint and then the knee buckled. Due to the play and buckling the patient lost balance and fell off his 4 foot porch/deck. The patient suffers a broken ankle, cracked breast plate, cracked rib, hip pain and lower back pain. He can't lift his left arm. He has a head laceration and was knocked out unconscious upon impact. He went to hospital for immediate trauma care and stayed overnight. In hospital the patient received mri scan, x-ray scan and temporary casting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2020-00001 |
| MDR Report Key | 9778587 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-03 |
| 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 | OTTOBOCK SE & CO KGAA |
| 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 | 3R60 |
| Product Code | ISY |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 3R60 |
| Catalog Number | 3R60 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTOBOCK SE & CO KGAA |
| Manufacturer Address | MAX-NAEDER-STR. 15 DUDERSTADT, 37115 GM 37115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-03 |