Digital Therapist

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE MEMBER EXPERIENCED SEVERE KNEE PAIN FOLLOWING COMPLETION OF A THERAPY SESSION AND SUBSEQUENTLY REPORTED A KNEE FRACTURE REQUIRING SURGICAL INTERVENTION. NO MEDICAL RECORDS OR DIAGNOSTIC IMAGING CONFIRMING THE REPORTED FRACTURE HAVE BEEN PROVIDED TO THE MANUFACTURER. THE MEMBER IDENTIFIED A SINGLE-LEG BALANCE EXERCISE INVOLVING STANDING ON ONE LEG WHILE FLEXING THE OPPOSITE KNEE TO APPROXIMATELY 90 DEGREES FOR 30 SECONDS AS THE EXERCISE ASSOCIATED WITH THE ONSET OF SYMPTOMS. AT PRESENT, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE REPORTED FRACTURE. A FIRST REVIEW OF THE EXERCISE METRICS IDENTIFIED NO FLAGGED TECHNICAL ISSUES DURING THE COMPLETED SESSIONS. THE MEMBER DID NOT REPORT ANY DEVICE MALFUNCTION OR TECHNICAL ISSUE AND ATTRIBUTED THE EVENT TO PERFORMANCE OF A SPECIFIC PRESCRIBED EXERCISE RATHER THAN TO DEVICE FUNCTIONALITY. AS PART OF THE ONGOING CLINICAL ASSESSMENT, THE MANUFACTURER NOTED THAT THE MEMBER HAD PREVIOUSLY COMPLETED THE IDENTICAL THERAPY SESSION, INCLUDING THE SAME EXERCISES AND REPETITIONS, ON (B)(6) 2026 WITHOUT ANY REPORTED ADVERSE EVENTS. AT THE SUBSEQUENT REASSESSMENT ON (B)(6) 2026, THE MEMBER REPORTED A SMALL BUT NOTICEABLE IMPROVEMENT IN THEIR CONDITION SINCE STARTING THE PROGRAM, WITH IMPROVED PAIN (FROM 4/10 TO 0/10), AND DISABILITY (FROM 7/10 TO 0/10 ACTIVITY IMPAIRMENT). THE MEMBER'S BASELINE ACTIVITIES INCLUDED KICKBOXING AND REGULAR DOG WALKING. DURING THE SESSION OF (B)(6) 2026, THE MEMBER REPORTED A POST-SESSION PAIN SCORE OF 2/10, WHICH WAS LOWER THAN PAIN LEVELS REPORTED DURING PRIOR SESSIONS, AND COMPLETED THE EXERCISES FOLLOWING THE IDENTIFIED SINGLE-LEG BALANCE EXERCISE. THE REPORTED KNEE FRACTURE WAS FIRST COMMUNICATED APPROXIMATELY ONE WEEK AFTER THE THERAPY SESSION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, INCLUDING THE ABSENCE OF MEDICAL DOCUMENTATION CONFIRMING THE FRACTURE AND THE LACK OF EVIDENCE OF DEVICE MALFUNCTION, THE MANUFACTURER IS UNABLE TO ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE REPORTED INJURY AND USE OF THE DEVICE. THE INVESTIGATION REMAINS ONGOING. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF SIGNIFICANT NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

ON 26-MAY-2026, THE MEMBER REPORTED THAT AFTER COMPLETING THEIR EIGHTH SESSION USING DIGITAL THERAPIST, PERFORMED ON (B)(6) 2026, THEY EXPERIENCED SEVERE KNEE PAIN THAT BECAME CONSTANT AND UNBEARABLE. THE MEMBER REPORTED ICING AND ELEVATING THE AFFECTED KNEE; HOWEVER, THE PAIN PERSISTED. IN RESPONSE TO THE REPORT, THE PHYSICAL THERAPIST REQUESTED THE MEMBER TO IDENTIFY THE EXERCISE ASSOCIATED WITH THE ONSET OF PAIN AND PROVIDED GUIDELINES REGARDING MODIFYING OR DISCONTINUING ANY EXERCISE THAT INCREASED PAIN. ON (B)(6) 2026, IN RESPONSE TO THE PHYSICAL THERAPIST'S FOLLOW-UP, THE MEMBER INFORMED THEM THAT THEY HAD A KNEE FRACTURE AND WOULD BE UNABLE TO CONTINUE THERAPY PENDING SURGERY. AT THIS TIME, NO MEDICAL EVIDENCE OF THE KNEE FRACTURE WAS PROVIDED TO THE MANUFACTURER. THE MEMBER IDENTIFIED THE EXERCISE ASSOCIATED WITH THE ONSET OF PAIN AS A SINGLE-LEG BALANCE EXERCISE PERFORMED WHILE BENDING THE OPPOSITE KNEE TO APPROXIMATELY 90 DEGREES AND HOLDING THE POSITION FOR 30 SECONDS. FOLLOWING THE REPORT OF THE KNEE FRACTURE, THE THERAPY PROGRAM WAS CLOSED. AN INITIAL REVIEW OF THE EXERCISE METRICS IDENTIFIED NO FLAGGED TECHNICAL ISSUES DURING THE COMPLETED SESSIONS. THE REPORTED KNEE FRACTURE REMAINS UNDER INVESTIGATION, AND THE RELATIONSHIP BETWEEN DEVICE USE AND THE REPORTED INJURY HAS NOT BEEN ESTABLISHED. .