BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
Received Jun 26, 2023 · Event occurred Jun 13, 2023
Report 3008108789-2023-00004 · MDR key 17200186
Device
Generic name
Toe Prosthesis
Manufacturer
Biopoly LlcModel number
135-5118Catalog number
135-5118
Lot number
2133830
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Pain
- Implant Pain
- Insufficient Information
- Pain
- Implant Pain
- Insufficient Information
Narrative
Additional Manufacturer Narrative
BIOPOLY RECEIVED THE EXPLANT FOR INSPECTION. THE EXPLANT WAS EXAMINED UNDER MAGNIFICATION, AND THERE WERE NO SIGNS OF VISIBLE WEAR. THE OSTEOSYNC MATERIAL WAS SECURELY ATTACHED TO THE STEM. THE IMPLANT HAD BEEN SECURED IN THE BONE VIA PRESS FIT; HOWEVER, THERE WAS NO EVIDENCE THAT BONE CEMENT HAD BEEN USED. THE IMPLANT MANUFACTURING LOT MET ALL SPECIFICATIONS. THERE WERE NO CONCERNS IDENTIFIED REGARDING THE EXPLANT THAT MAY HAVE LED TO THE PATIENT DEVELOPING STIFFNESS OR PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.
Description of Event or Problem
A PATIENT DEVELOPED JOINT STIFFNESS AND PAIN AND HAD THE BIOPOLY IMPLANT REMOVED.