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

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191); Swelling/ Edema (4577); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Causing anterior compartment syndrome where her left leg was 3 inches bigger than the right [compartment syndrome].Hurting so much [leg pain].Couldn't bend it [joint range of motion decreased].Pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out [swelling of legs].Cardiac event [cardiac disorder nos].Missed the joint and injected synvisc one in her lower leg [product administered at inappropriate site].Case narrative: based upon additional information received on 20-may-2020, this case initially assessed as non-serious was upgraded to serious.Further, this report had been initially processed as non-valid and was updated to a valid report.Initial information received on 15-may-2020 regarding an unsolicited valid serious case received from a consumer from united states.This case involves a female patient who experienced hurting so much, causing anterior compartment syndrome where her left leg was 3 inches bigger than the right, couldn't bend it, pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, cardiac event and missed the joint and injected synvisc one in her lower leg, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, concomitant medication(s), vaccination(s) and family history were not provided.Past drug included synvisc in 2018 in other knee.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate (formulation, dose, frequency, route and batch number unknown) for unknown indication.Information on batch number was requested.Patient stated that the physicians assistant missed the joint and injected synvisc once in her lower leg (latency: same day).On an unknown date in (b)(6) 2019, patient had a cardiac event (latency: unknown) and had a stent placed.On an unknown date, after unknown latency, patient experienced there were pillows of the product in pockets on the front of her leg (hospitalization, intervention required and disability) and stated that one could push these half inch pockets or pillows and they would spring back out (hospitalization, intervention required and disability).Patient was in the emergency room in a wheelchair for a couple days.While at the emergency room, she experienced it was hurting so much (onset and latency: unknown) (hospitalization, intervention required and disability) and she couldn't bend it (onset and latency: unknown) (hospitalization, intervention required and disability).She was given methylprednisolone (medrol dosepak) to get the swelling down and was told to go for physical therapy, which occurred right before covid19.The patient was told by the emergency room doctors that they were not equipped to handle her situation and she should consult an orthopedic.The orthopedic was worried that it was causing anterior compartment syndrome where her left leg was 3 inches bigger than the right (onset and latency: unknown) (hospitalization, intervention required and disability).She had tried hot and cold packs, exercise and stretching to help dissolve the swelling.The patients orthopedic had no idea and had not seen anything like this before and couldn't figure out a way to get the swelling down.Action taken: not applicable for all events.Corrective treatment: stent placed for cardiac event; wheelchair, methylprednisolone (medrol dosepak), physical therapy, hot and cold packs, stretching, exercise for pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, hurting so much, couldn't bend it and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right; not reported for missed the joint and injected synvisc one in her lower leg.Outcome: not applicable for missed the joint and injected synvisc one in her lower leg; unknown for rest of the events a product technical complaint was initiated with global ptc number (b)(4) and results were pending for the same.Additional information received on 18-may-2020 and 20-may-2020 from patient.Case updated to a valid and serious report.Global ptc number added.Patients gender added.Event verbatim updated from adverse event on synvisc one to pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out.Event of missed the joint and injected synvisc one in her lower leg, hurting so much, couldn't bend it, cardiac event and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right.Clinical course updated.Text amended accordingly.

Event Description

Causing anterior compartment syndrome where her left leg was 3 inches bigger than the right [compartment syndrome] hurting so much [leg pain] cardiac event [cardiac disorder nos] pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out [swelling of legs] couldnt bend it [joint range of motion decreased] missed the joint and injected synvisc one in her lower leg [product administered at inappropriate site] case narrative: based upon additional information received on 20-may-2020, this case initially assessed as non-serious was upgraded to serious.Further, this report had been initially processed as non-valid and was updated to a valid report.Initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from a consumer from united states.This case involves a female patient who experienced hurting so much, causing anterior compartment syndrome where her left leg was 3 inches bigger than the right, couldnt bend it, pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, cardiac event and missed the joint and injected synvisc one in her lower leg, while she was treated with with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, concomitant medication(s), vaccination(s) and family history were not provided.Past drug included synvisc in 2018 in other knee.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate (formulation, dose, frequency, route and batch number unknown) for unknown indication.Information on batch number was requested.Patient stated that the physicians assistant missed the joint and injected synvisc once in her lower leg (latency: same day; clinical course updated.Text amended accordingly).On an unknown date in (b)(6) 2019, patient had a cardiac event (latency: unknown; cardiac disorder) and had a stent placed.On an unknown date, after unknown latency, patient experienced there were pillows of the product in pockets on the front of her leg (hospitalization, intervention required and disability; peripheral swelling) and stated that one could push these half inch pockets or pillows and they would spring back out (hospitalization, intervention required and disability).Patient was in the emergency room in a wheelchair for a couple days.While at the emergency room, she experienced it was hurting so much (onset and latency: unknown; pain in extremity) (hospitalization, intervention required and disability) and she couldnt bend it (onset and latency: unknown; joint range of motion decreased) (hospitalization, intervention required and disability).She was given methylprednisolone (medrol dosepak) to get the swelling down and was told to go for physical therapy, which occurred right before covid19.The patient was told by the emergency room doctors that they were not equipped to handle her situation and she should consult an orthopedic.The orthopedic was worried that it was causing anterior compartment syndrome where her left leg was 3 inches bigger than the right (onset and latency: unknown; compartment syndrome) (hospitalization, intervention required and disability).She had tried hot and cold packs, exercise and stretching to help dissolve the swelling.The patients orthopedic had no idea and had not seen anything like this before and couldnt figure out a way to get the swelling down.It was reported that the knee injection did not cause the leg pain.Action taken: not applicable for all events corrective treatment: stent placed for cardiac event; wheelchair, methylprednisolone (medrol dosepak), physical therapy, hot and cold packs, stretching, exercise for pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, hurting so much, couldnt bend it and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right; not reported for missed the joint and injected synvisc one in her lower leg outcome: not applicable for missed the joint and injected synvisc one in her lower leg; unknown for rest of the events a product technical complaint was initiated with global ptc number 100044746 and results were pending for the same.Reporter causality: not related for pain in extremity additional information received on 18-may-2020 and 20-may-2020 from patient.Case updated to a valid and serious report.Global ptc number added.Patients gender added.Event verbatim updated from adverse event on synvisc one to pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out.Event of missed the joint and injected synvisc one in her lower leg, hurting so much, couldnt bend it, cardiac event and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right.Clinical course updated.Text amended accordingly.Follow up information received on 28-may-2020 from other healthcare professional.Global ptc number added.No significant information additional information received on 25-jan-2021 from the patient.Reporter causality for pain in extremity updated to not related.Clinical course updated.Text amended accordingly.

Event Description

Causing anterior compartment syndrome where her left leg was 3 inches bigger than the right [compartment syndrome] couldn't bend it [joint range of motion decreased] pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out [swelling of legs] hurting so much/leg pain [leg pain] cardiac event [cardiac disorder] missed the joint and injected synvisc one in her lower leg with no reported adverse event [product administered at inappropriate site].Case narrative: based upon additional information received on 20-may-2020, this case initially assessed as non-serious was upgraded to serious.Further, this report had been initially processed as non-valid and was updated to a valid report.Initial information received on 15-may-2020 regarding an unsolicited valid serious case received from a consumer from united states.This case involves an adult female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and reported that it was causing anterior compartment syndrome where her left leg was 3 inches bigger than the right, could not bend it, hurting so much/leg pain, pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, and cardiac event.Also, it was reported that missed the joint and injected synvisc one in her lower leg with no adverse event reported directly linked to this product administered at inappropriate.The patient's past medical history, concomitant medication(s), vaccination(s) and family history were not provided.Past drug included synvisc in 2018 in other knee.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate, injection liquid (solution), 48 mg/6ml (dose, frequency, route, batch number, expiry date, indication: unknown).Information on batch number was requested.Patient stated that the physicians assistant missed the joint and injected synvisc once in her lower leg (latency: same day; product administered at inappropriate site).On an unknown date in (b)(6) 2019, patient had a cardiac event (latency: unknown; cardiac disorder) and had a stent placed.On an unknown date, after unknown latency, patient experienced there were pillows of the product in pockets on the front of her leg and stated that one could push these half inch pockets or pillows and they would spring back out (hospitalization, intervention required and disability; peripheral swelling).Patient was in the emergency room in a wheelchair for a couple days.While at the emergency room, she experienced it was hurting so much (onset and latency: unknown; pain in extremity) (hospitalization, intervention required and disability) and she could not bend it (onset and latency: unknown; joint range of motion decreased) (hospitalization, intervention required and disability).She was given methylprednisolone (medrol dosepak) to get the swelling down and was told to go for physical therapy, which occurred right before covid 19.The patient was told by the emergency room doctors that they were not equipped to handle her situation and she should consult an orthopedic.The orthopedic was worried that it was causing anterior compartment syndrome where her left leg was 3 inches bigger than the right (onset and latency: unknown; compartment syndrome) (hospitalization, intervention required and disability).She had tried hot and cold packs, exercise and stretching to help dissolve the swelling.The patients orthopedic had no idea and had not seen anything like this before and could not figure out a way to get the swelling down.It was reported that the knee injection did not cause the leg pain.Action taken: not applicable for all events.Corrective treatment: stent placed for cardiac event; wheelchair, methylprednisolone (medrol dosepak), physical therapy, hot and cold packs, stretching, exercise for pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out, hurting so much, could not bend it and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right.Outcome: unknown for all the events.Reporter causality: not related for pain in extremity.A product technical complaint was initiated with global ptc number 100044746 on 15-may-2020 for synvisc one, batch number: unknown.Sample of ptc was not available.Ptc stated: the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective action and preventive action) is required.It is 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 (non-conformance) 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 will continue to monitor adverse events to determine if a capa is required.Investigation reopened by complaint officer on 09-jun-20 to forward investigation summary to pv as additional information was received by parexel and added to the complaint.No change to investigation.- dd 09jun2020.The final investigation was completed on 09-jun-2020 with summarized conclusion as no assessment possible.Additional information received on 18-may-2020 and 20-may-2020 from patient.Case updated to a valid and serious report.Global ptc number added.Patients gender added.Event verbatim updated from adverse event on synvisc one to pillows of the product in pockets on the front of her leg/ push these half inch pockets or pillows and they would spring back out.Event of missed the joint and injected synvisc one in her lower leg, hurting so much, couldn't bend it, cardiac event and causing anterior compartment syndrome where her left leg was 3 inches bigger than the right.Clinical course updated.Text amended accordingly.Follow up information received on 28-may-2020 from other healthcare professional.Global ptc number added.No significant information.Additional information received on 25-jan-2021 from the patient.Reporter causality for pain in extremity updated to not related.Clinical course updated.Text amended accordingly.Additional information received on 09-jun-2020 from quality department (other healthcare professional).Product strength and ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 10127840
• MDR Text Key: 201706357
• Report Number: 2246315-2020-00070
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Sex: Female