MalfunctionLWJ
STELKAST HIP ARTHROPLASTY
Received Mar 5, 2024 · Event occurred Dec 19, 2022
Report 3004142400-2023-00051 · MDR key 18834167
Device
Generic name
Provident Hip Stem, Lateral, 10mm
Manufacturer
Globus Medical, Inc.Model number
SC2658-10.0Lot number
42711
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A REVISION WAS NEEDED TO REPLACE A STELKAST HIP IMPLANT THAT FAILED POST OPERATIVELY.
Additional Manufacturer Narrative
THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. THE DEVICE COULD NOT BE PROVIDED FOR EVALUATION. THE IMAGING PROVIDED SHOWS THE FEMORAL HEAD CENTER OF ROTATION APPEARS TO SHIFT LATERALLY. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.