MalfunctionMAY
HIP JOINT REPLACEMENT
Received Jan 4, 2024 · Event occurred Dec 30, 2023
Report MW5149866 · MDR key 18457424
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Smith & Nephew, Inc.Patient
Unknown
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS CONVERT FROM A COMPETITOR CEMENT CUP TO A PINNACLE CONSTRAINED. THE LOOSENING INTERFACE WAS CEMENT TO IMPLANT. COMPETITOR CEMENT WAS USED. UNKNOWN SURGICAL DELAY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).