MERIDIUM
Received Jan 13, 2022 · Event occurred Jan 3, 2022
Report 9615892-2022-00001 · MDR key 13247200
Device
Generic name
External Ankle/foot Prosthetic Component
Manufacturer
Otto Bock Healthcare Products GmbhModel number
1B1=L27Catalog number
1B1=L27
Product problems
- Unintended System Motion
- Unintended System Motion
Patient
Male
- Fall
- Hip Fracture
- Fall
- Hip Fracture
Narrative
Description of Event or Problem
INCORRECT JOINT BEHAVIOR: FOOT DOES NOT HOLD FORWARD RESISTANCE. PATIENT CANNOT TELL IF THE FALL HAPPENED BECAUSE OF A DEFECT IN THE FOOT. PATIENT NO LONGER WANTS THE FOOT. PATIENT FELL AND BROKE NECK OF FEMUR. THE CLIENT FELL AND SUFFERED A FRACTURE OF THE NECK OF THE FEMUR. PATIENT FELL WHILE WALKING THE DOG OUTSIDE. FOOT BEEPED, BUZZED AND GAVE AN ERROR MESSAGE. AS SAID BEFORE, THE PATIENT IS NOT SURE IF HE FELL BECAUSE OF THE FOOT OR POSSIBLY BECAUSE OF SOMETHING ELSE.
Additional Manufacturer Narrative
DEVICE EVALUATION IN PROGRESS; SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.
Additional Manufacturer Narrative
EVALUATION AND INVESTIGATION OF THE DEVICE SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.