inforMED
MalfunctionMAY

26MM+4MM SKIRTLESS V40 HD TRL

Received Feb 7, 2017 · Event occurred Jan 12, 2017

Report 0002249697-2017-00487 · MDR key 6309292

Device

Generic name

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porou

Catalog number

6264-7-226

Lot number

SS162703

Product problems

  • Break
  • Disassembly
  • Improper or Incorrect Procedure or Method
  • Device Dislodged or Dislocated
  • Material Integrity Problem
  • Break
  • Disassembly
  • Material Integrity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • Joint Dislocation
  • No Consequences Or Impact To Patient
  • Joint Dislocation

Narrative

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

DURING THA, THE SURGEON TRIED TO TRIAL REDUCTION BY THE CUP TRIAL AND THE HEAD TRIAL(26MM/0MM). AFTER TRIAL REDUCTION, THE SURGEON CONFIRMED THE HEAD TRIAL HAD COME OFF OF THE NECK OF STEM. THEREFORE, THE SURGEON TRIED TO TRIAL REDUCTION BY THE HEAD TRIAL(26MM/+4MM) AGAIN. AFTER TRIAL REDUCTION, THE SURGEON MADE THEM DISLOCATE THE HIP JOINT OF PATIENT, AND TRIED TO REMOVE THE HEAD TRIAL. BUT, THE HEAD TRIAL FIXED ON THE STEM NECK SLANTINGLY, AND DISLOCATION BECOME DIFFICULT. THE SURGEON BROKE THE HEAD TRIAL BY THE CHISEL.

Additional Manufacturer Narrative

AN EVENT REGARDING DISASSEMBLY ISSUES LEADING TO FRACTURE INVOLVING A PARTNERSHIP TRIAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RECEIVED WITH MULTIPLE PIECES FRACTURED OFF. THE FRACTURE SURFACE WAS EXAMINED BY THE MATERIAL ANALYSIS TEAM WHO INDICATED THAT "DEVICE FRACTURED DUE TO AN OVERLOAD CONDITION AS INDICATED BY THE HACKLES OBSERVED ON THE FRACTURE SURFACE." MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS IT IS NOT BELIEVED THAT PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE REPORTED EVENT STATES THAT THE SURGEON WAS UNABLE TO REMOVE THE HEAD TRIAL FROM STEM NECK BECAUSE IT WAS FIXED SLANTINGLY. VISUAL INSPECTION NOTED THE DEVICE WAS RECEIVED WITH MULTIPLE PIECES FRACTURED OFF. THE FRACTURE SURFACE WAS EXAMINED BY THE MATERIAL ANALYSIS TEAM WHO INDICATED THAT "DEVICE FRACTURED DUE TO AN OVERLOAD CONDITION AS INDICATED BY THE HACKLES OBSERVED ON THE FRACTURE SURFACE."REVIEW OF THE SURGICAL PROTOCOL INCLUDES SPECIFIC INSTRUCTIONS ON HOW TO SUCCESSFULLY ASSEMBLE AND DISASSEMBLE THE TRIAL HEAD FROM THE STEM NECK. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME.

Description of Event or Problem

DURING THA, THE SURGEON TRIED TO TRIAL REDUCTION BY THE CUP TRIAL AND THE HEAD TRIAL(26MM/0MM). AFTER TRIAL REDUCTION, THE SURGEON CONFIRMED THE HEAD TRIAL HAD COME OFF OF THE NECK OF STEM. THEREFORE, THE SURGEON TRIED TO TRIAL REDUCTION BY THE HEAD TRIAL(26MM/+4MM) AGAIN. AFTER TRIAL REDUCTION, THE SURGEON MADE THEM DISLOCATE THE HIP JOINT OF PATIENT, AND TRIED TO REMOVE THE HEAD TRIAL. BUT, THE HEAD TRIAL FIXED ON THE STEM NECK SLANTINGLY, AND DISLOCATION BECOME DIFFICULT. THE SURGEON BROKE THE HEAD TRIAL BY THE CHISEL.