inforMED
MalfunctionHSA

INBONE®

Received Mar 1, 2017 · Event occurred Feb 6, 2017

Report 1043534-2017-00024 · MDR key 6368320

Device

Generic name

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

Model number

200012902

Lot number

1538367

Product problems

  • Break
  • Disassembly
  • Break
  • Disassembly

Patient

46 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE PARTS WERE RETURNED. THE TOP AND MID STEM WERE RETURNED SEATED TOGETHER AND THE BASE STEM WAS RETURNED SEPARATE. VISUAL INSPECTION SHOWS NO OVERALL GROSS DEFORMATION. THERE WAS NO DAMAGE TO THE FEMALE THREADS OF THE BASE STEM OR THE MALE THREAD OF THE MID STEM. ALSO, REVIEW OF THE MID STEM THREADING DID NOT SHOW ANY DEFORMATION OR OBSTRUCTION THAT WOULD PREVENT THE BASE STEM FROM SEATING PROPERLY. THE BASE STEM WAS ABLE TO BE SEATED ON THE MID STEM WITHOUT ANY ISSUES. RADIOGRAPHIC IMAGES WERE PROVIDED AND SHOW THE BASE STEM SEPARATED FROM THE MID STEM.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER FILMS WERE SUPPLIED FOR REVIEW. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. ASSOCIATED WITH REPORTS 1043534-2017-00025 AND 1043534-2017-00026.

Description of Event or Problem

ALLEGEDLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANKLE SURGICAL PROCEDURE. APPROXIMATELY 8 MONTHS POST-OP, IT WAS FOUND THAT THE TIBIAL STEM IMPLANTS ARE DISASSOCIATED OR BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.