MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Joint Disorder (2373); Joint Dislocation (2374); Sweating (2444); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee) [bursal fluid accumulation], ([local swelling]) dislocated her left knee cap with the fall [dislocated patella], synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet [clammy], synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet [fall], off label use (left knee) [off label use of device].Case narrative: this case is linked to case (b)(4) (same patient, multiple devices, right knee).Initial information was received from united states on 09-sep-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a (b)(6) years old female patient who experienced swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee), dislocated her left knee cap with the fall, synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet, and off label use (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] in left knee.The patient's past vaccination(s) and family history were not provided.The patient's past medical history included bilateral baker's cysts on her knees.At the time of the event, the patient had ongoing multiple sclerosis (diagnosed 40 years ago) and multiple allergies.Reportedly, she has 27 allergies and could not take any type of pain relief.She had two rounds of cortisone injections before the synvisc one.Reportedly, the patient had not previously received synvisc one.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection, in left knee, for osteoarthritis (dose, frequency, route and lot - unknown).Information on lot number was requested.On same day of injection, off label use of device was reported (reason not specified).On an unknown date in (b)(6) 2020 ((b)(6)), 24-36 hours later after the injection, she noticed that both her feet were damp (cold sweat).She slipped on the kitchen floor and fell due to this (fall, latency: few hours).She dislocated her left kneecap with the fall (joint dislocation, latency: few hours).The patient mentioned that the synvisc one she received was leaking out of both her feet.Her orthopedic doctor had done many x-rays, two mri's (magnetic resonance imaging) and a sonogram (ultrasound) on her knees.He ortho doctor stated that she had bursa sacks below each knee, and he wanted to drain them to see what the fluid was (bursal fluid accumulation; latency: unknown).The clammy feet (cold sweat) persisted to the present ((b)(6) 2020).As of (b)(6) 2020, she had a swollen area (swelling) below both knees that were about 2" long and 1.5 inches wide.She was having pt (physical therapy) and walked with crutches or walker.She will have those areas drained next tuesday ((b)(6) 2020).The events of joint dislocation and bursal fluid accumulation were assessed to cause disability to the patient.She did not have the lot number or expiration date of the product she received.Final diagnosis was swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee), off label use, synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet and dislocated her left knee cap with the fall.Action taken: not applicable for all the events.Corrective treatment: pt (physical therapy) and walked with crutches or walker for bursal fluid accumulation and joint dislocation; not reported for rest all events.Outcome: not recovered / not resolved for cold sweat, and bursal fluid accumulation; as unknown for fall and joint dislocation; and as not applicable for off label use.A product technical complaint (ptc) was initiated and results were pending for the same.

Event Description

Swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee) [bursal fluid accumulation] ([local swelling]) dislocated her left knee cap with the fall [dislocated patella] synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet [clammy] synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet [fall] off label use (left knee) [off label use of device].Case narrative: this case is linked to case (b)(4) (same patient, multiple devices, right knee).Initial information was received from united states on 09-sep-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 64 years old female patient who experienced swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee), dislocated her left knee cap with the fall, synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet, and off label use (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] in left knee.The patient's past vaccination(s) and family history were not provided.The patient's past medical history included bilateral baker's cysts on her knees.At the time of the event, the patient had ongoing multiple sclerosis (diagnosed 40 years ago) and multiple allergies.Reportedly, she has 27 allergies and could not take any type of pain relief.She had two rounds of cortisone injections before the synvisc one.Reportedly, the patient had not previously received synvisc one.On (b)(6) 2020, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection, in left knee, for osteoarthritis (dose, frequency, route and lot - unknown).Information on lot number was requested.On same day of injection, off label use of device was reported (reason not specified).On an unknown date in (b)(6) 2020 ((b)(6)), 24-36 hours later after the injection, she noticed that both her feet were damp (cold sweat).She slipped on the kitchen floor and fell due to this (fall, latency: few hours).She dislocated her left kneecap with the fall (joint dislocation, latency: few hours).The patient mentioned that the synvisc one she received was leaking out of both her feet.Her orthopedic doctor had done many x-rays, two mri's (magnetic resonance imaging) and a sonogram (ultrasound) on her knees.He ortho doctor stated that she had bursa sacks below each knee, and he wanted to drain them to see what the fluid was (bursal fluid accumulation; latency: unknown).The clammy feet (cold sweat) persisted to the present ((b)(6) 2020).As of 09-sep-2020, she had a swollen area (swelling) below both knees that were about 2" long and 1.5 inches wide.She was having pt (physical therapy) and walked with crutches or walker.She will have those areas drained next tuesday ((b)(6) 2020).The events of joint dislocation and bursal fluid accumulation were assessed to cause disability to the patient.She did not have the lot number or expiration date of the product she received.Final diagnosis was swollen area below both knees that are about 2" long and 1.5 inches wide/bursa sacks below each knee and he wants to drain them to see what the fluid is (left knee), off label use, synvisc one she received is leaking out of both her feet/both her feet were damp/slipped on the kitchen floor and fell due to this/clammy feet and dislocated her left knee cap with the fall.Action taken: not applicable for all the events.Corrective treatment: pt (physical therapy) and walked with crutches or walker for bursal fluid accumulation and joint dislocation; not reported for rest all events.Outcome: not recovered / not resolved for cold sweat, and bursal fluid accumulation; as unknown for fall and joint dislocation; and as not applicable for off label use.A product technical complaint (ptc) was initiated on 09-sep-2020 for synvisc one (lot number unknown) global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation was completed on 21-sep-2020.Follow up information was received on 09-sep-2020 from other health professional.Global ptc number was added.No significant information was received.Additional information was received on 21-sep-2020 from other healthcare professional.Ptc results were received and processed.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10545685
• MDR Text Key: 213858123
• Report Number: 2246315-2020-00135
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORTISONE (CORTISONE),INJECTION.; CORTISONE (CORTISONE),INJECTION.
• Patient Outcome(s): Required Intervention; Disability