MalfunctionISH
OTTO BOCK AXTION® PROSTHETIC FOOT
Received Jul 19, 2016 · Event occurred Apr 21, 2012
Report 1721652-2016-00003 · MDR key 5807182
Device
Generic name
1e56 Axtion Prosthetic Foot
Manufacturer
Otto Bock Healthcare LpModel number
1E56=N29-3-P/0Catalog number
1E56=N29-3-P/0
Product problems
- Migration or Expulsion of Device
Patient
32 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
RECENTLY OTTO BOCK HEALTHCARE LP PERFORMED A RETROSPECTIVE REVIEW ACROSS ALL PRODUCTS MANUFACTURED IN (B)(4). DURING THE REVIEW THIS MALFUNCTION WAS DISCOVERED AND IT WAS DETERMINED TO BE REPORTABLE BASED ON THE CRITERIA OUTLINED IN 21 CFR 803.
Description of Event or Problem
METAL ATTACHMENT ON TOP OF FOOT HAD SHEARED OFF ALTOGETHER, CAUSING FOOT TO PART COMPANY WITH THE REST OF PROSTHESIS. PATIENT REPORTED INCIDENT BY PHONE - ONE BROKEN FINGER AND BRUISED/BROKEN RIBS AFTER HE FELL.
Remedial action
- Replace