REMEDY SPECTRUM GV HIP
Received Dec 30, 2020 · Event occurred Dec 8, 2020
Report 3010537287-2020-00009 · MDR key 11096300
Device
Generic name
Hip Spacer, Product Code: Kwl
Manufacturer
Osteoremedies, LlcCatalog number
GVHDSM
Lot number
OR01041
Product problems
- Break
- Material Integrity Problem
- Break
- Material Integrity Problem
Patient
56 YR
- Failure of Implant
- Limited Mobility Of The Implanted Joint
- Failure of Implant
- Limited Mobility Of The Implanted Joint
Narrative
Additional Manufacturer Narrative
THE USE OF CEMENT ON THE THREADS CONTRIBUTED TO THE DIFFICULTY AFFIXING THE HEAD TO THE STEM. THE EXTRA FORCE USED TO THREAD THE HEAD CAUSED THE HEAD IMPLANT TO BREAK. NO PATIENT HARM WAS REPORTED ONLY A DELAY IN SURGERY OF GREATER THAN 60 MINUTES.
Description of Event or Problem
WHEN AFFIXING THE HEAD TO THE STEM PRIOR TO IMPLANTATION, THE SURGEON CHOSE TO USE BONE CEMENT ON THE THREADS. DUE TO THE BONE CEMENT SETTING UP THE SURGICAL TECHNICIAN HAD DIFFICULTY THREADING THE HEAD ONTO THE STEM. THE SURGEON ALSO ATTEMPTED TO THREAD THE HEAD DOWN AND DUE TO AMOUNT OF FORCE BEING APPLIED THE HEAD IMPLANT BROKE. THE SURGERY WAS DELAYED FOR OVER 60 MINUTES WHILE ANOTHER HEAD IMPLANT WAS OBTAINED. THERE WAS NO REPORTED ADVERSE EVENT REPORTED FOR THE PATIENT DUE TO THE SURGICAL DELAY.