FDA Adverse Event
Injury
Summary report: N
GENIUM X3
MDR report key: 7572793
·
Received June 6, 2018
Report
- Report Number
- 9615892-2018-00015
- Event Type
- Injury
- Date Received
- June 6, 2018
- Date of Event
- April 25, 2018
- Report Date
- June 25, 2018
- Manufacturer
- OTTO BOCK HEALTHCARE PRODUCTS GMBH
- Product Code
- ISY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
EVALUATION AND INVESTIGATION OF THE KNEE JOINT SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.
Additional Manufacturer Narrative · 1
DEVICE IS CURRENTLY NOT AVAILABLE FOR EVALUATION (NOT RETURNED FROM OB (B)(4) YET); SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER EVALUATION OF ALL DEVICE COMPONENTS IS COMPLETED.
Description of Event or Problem · 1
PATIENT STUMBLED OVER A CABLE AND FELL. ACCORDING TO REPORT NO MALFUNCTION OF THE JOINT NOTICEABLE. THE INCIDENT OCCURRED AROUND THE END OF (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418708 | GENIUM X3 | EXTERNAL ABOVE KNEE PROSTHESIS | ISY | OTTO BOCK HEALTHCARE PRODUCTS GMBH | 3B5-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |