DUROLANE GEL INJECTIONS

Description of Event or Problem

I RECEIVED DUROLANE GEL INJECTIONS IN BOTH KNEES ON (B)(6) 2025. THE MEDICATION CAUSE SWELLING AND PAIN. ON (B)(6) 2025 THE PHYSICIAN REMOVED FLUID FROM BOTH KNEES AS A RESULT OF THE DRUG INTERACTIONS. OVER THE NEXT 6 WEEKS, FLUID WAS REMOVED THREE MORE TIMES BY THE PHYSICIAN. THE PHYSICIAN ADVISED THAT THE DUROLANE GEL INJECTIONS CAUSE THE BONE ENDS TO DEGRADE CAUSING THE JOINTS TO BECOME BRITTLE. BOTH KNEES NOW NEED A TOTAL REPLACEMENT. MY LEFT KNEE WAS REPLACED ON (B)(6) 2026. THE RIGHT KNEE IS SCHEDULED FOR TOTAL REPLACEMENT IN (B)(6) 2026. A REPORT WAS MADE TO THE MANUFACTURER AND NO RESPONSE HAS BEEN RECEIVED AS OF THIS TIME. I HAVE RETAINED ALL MEDICAL RECORDS, REPORTS AND NOTES FROM BOTH THE PHYSICIAN AND SURGICAL CENTER. PATIENT CODE: 1994, 4577. DEVICE CODE: 4001. REFERENCING REPORT MW5187791.

Description of Event or Problem

ON (B)(6) 2026, THE LEFT KNEE WAS SURGICALLY REPLACED DUE TO THE DAMAGES OF THE INJECTIONS. IN (B)(6) I CONTACTED THE BIOVENTUS/DUROLANE HOTLINE AND FILED A FORMAL WRITTEN COMPLAINT WITH AGENT (B)(4). I WAS TOLD THAT A COMPANY DOCTOR WOULD CONTACT ME TO DISCUSS THIS ISSUE. OVER THE NEXT FOUR WEEKS, I CONTACTED THE BIOVENTUS/DUROLANE HOTLINE AND WAS ADVISE THAT THE MATTER (B)(4) AND ONE OTHER REPRESENTATIVE (NAME UNKNOWN) WHO STATED THAT THE MATTER WAS ASSIGNED TO (B)(4) IN THEIR INVESTIGATIONS TEAM. THEY ALSO ADVISED THAT (B)(4) HAD BEEN EMAILED AND CONTACTED VIA VOICEMAILS WITH NO RESPONSE. MY SURGEON HAD ADVISED THAT (B)(4) HAD CONTACTED HIS PRACTICE AND WHILE ONLY THE PHYSICIAN CAN ATTEST TO THE CONVERSATION, I WAS TOLD THE EXCHANGE WAS VOLATILE WITH SOME THREATS FROM THE CALLER. NOW, NEARLY EIGHT WEEKS AFTER THE ORIGINAL CONTACT TO THE MANUFACTURER, IT APPEARS TO BE AN INTENTIONAL ACT OF AVOIDANCE. UPDATE ON THIS MATTER: THE DUROLANE GEL INJECTIONS (CONSIDERED A MEDICAL DEVICE) CAUSED BILATERAL KNEE FAILURE, RESULTING IN TOTAL KNEE REPLACEMENT SURGERY ON THE LEFT WITH THE RIGHT PENDING. ON (B)(6) 2026 INTERIOR SUTURES ON THE LEFT KNEE REPLACEMENT FAILED AND CAUSE A BLOOD WITH RESULTED IN A STROKE AND ICU HOSPITALIZATION. NONE OF WHICH WOULD HAVE OCCURRED IF THE DUROLANE GEL INJECTIONS HADN'T CAUSE THE BONE DEGRADING. I RESPECTFULLY REQUEST ASSISTANCE WITH THE INVESTIGATIVE MATTER AS RELATED TO THIS COMPLAINT. PATIENT CODES: 1770, 4559 AND 1924.