BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
Received Apr 10, 2023 · Event occurred Nov 1, 2022
Report 3008108789-2023-00001 · MDR key 16709848
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Inadequate Osseointegration
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
BIOPOLY DID NOT RECEIVE EXPLANT FOR INSPECTION. EXISTENCE OF PERIPROSTHETIC BONE ABSORPTION WAS UNEXPLAINED, AND THE LOT OF IMPLANTS WAS CONFIRMED AS MANUFACTURED TO SPECIFICATIONS. LOSS OF FIXATION OF THE IMPLANT IS A POSSIBLE ADVERSE EFFECT LISTED IN THE INSTRUCTIONS FOR USE (IFU) DOCUMENT, AND A CONSIDERED RISK IN THE RISK MANAGEMENT SYSTEM FOR THIS IMPLANT. MANY POSSIBLE FACTORS COULD LEAD TO LOSS OF IMPLANT FUNCTION, INCLUDING FAILURE TO FOLLOW INSTRUCTIONS FOR USE, DAMAGE TO THE IMPLANT DURING IMPLANTATION, USE OF IMPLANT AGAINST NON-CARTILAGE SURFACE, OR IMPROPER PATIENT SELECTION (AGE, BONE QUALITY, CARTILAGE HEALTH). IF ADDITIONAL INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.
Description of Event or Problem
BIOPOLY LEARNED FROM PHYSICIAN ABOUT OSTEOLYSIS/BONE RESORPTION IN ONE OF HIS PATIENTS, AND THAT HE REMOVED THE BIOPOLY IMPLANT. PHYSICIAN THOUGHT THAT THE AREA WAS INFECTED AS HIS PATIENT HAD SOME POSTOPERATIVE WOUND COMPLICATIONS, BUT ALL CULTURES WERE NEGATIVE UPON IMPLANT REMOVAL, AND THERE WERE NO SIGNS OF INFECTION. PHYSICIAN ORIGINALLY SUSPECTED INFECTION OR RAPID POLYETHYLENE DISEASE AS A CAUSE FOR PERI-IMPLANT BONE RESORPTION; HOWEVER, THERE WAS NO SIGN OF IMPLANT WEAR.