ASA 'MPHI FAMILY DIODE LASER

Description of Event or Problem

I RECEIVED 6 "ORTHOLAZER" TREATMENT SESSIONS AT THEIR DEDHAM, MA FACILITY FOLLOWING ARTHROSCOPIC SURGERY ON MY RIGHT KNEE. THE 6 SESSIONS TOOK PLACE BETWEEN (B)(6) 2024 AND (B)(6) 2024. THE FDA CLEARANCE NUMBER FOR THE DEVICE USED IS (B)(4). ON (B)(6)2024 I DEVELOPED HEMARTHROSIS IN MY RIGHT KNEE. THE BLOOD (30CC) WAS ASPIRATED ON (B)(6) 2024. HEMARTHROSIS RECURRED ON (B)(6)2024 AND 40CC BLOOD WAS ASPIRATED FROM THE KNEE ON (B)(6)2024. HEMARTHROSIS IS GENERALLY ASSOCIATED WITH TRAUMA OR BLOOD DYSCRASIA, NEITHER OF WHICH APPLY IN THIS CASE. ANALYSIS OF THE ASPIRATE WAS PERFORMED AS WELL AS EXTENSIVE BLOOD WORK, ALL OF WHICH WAS NORMAL (OTHER THAN LONGSTANDING MILD ANEMIA). MOST CONCERNING, AN MRI PERFORMED AFTER THE HEMARTHROSIS INDICATES AN AREA OF OSTEONECROSIS OF THE POSTERIOR MEDIAL AND POSTERIOR LATERAL FEMORAL CONDYLES. OSTEONECROSIS WAS NOT PRESENT AT THE PREVIOUS MRI ON (B)(6) 2024. TO QUOTE THE RADIOLOGY REPORT: IMPRESSION: 1. POSTOPERATIVE CHANGES FROM PARTIAL MEDIAL MEISCECTOMY WITHOUT EVIDENCE OF RETEAR. 2. OSTEONECROSIS OF THE POSTERIOR WEIGHTBEARING MEDIAL LATERAL FEMORAL CONDYLES, NEW SINCE (B)(6) 2024. 3. SUBCHONDRAL SIGNAL ABNORMALITY ALONG THE ANTERIOR WEIGHBEARING LATERAL FEMORAL CONDYLE COULD REFLECT AN ADDITIONAL SITE OF OSTEONECROSIS OR COULD REFLECT A SUBCHONDRAL FRACTURE. 4. PATELLOFEMORAL COMPARTMENT PREDOMINANT DEGENERATIVE CHANGES, SIMILAR TO PRIOR. ASA "MPHI FAMILY" DIODE LASER (ORTHOLAZER ADVERTISES THAT THEY USE THE "MLS M8 ROBOTIC LASER".