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

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

Patient Problems Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2001

Event Type  Injury  

Event Description

Allergic reaction to the synvisc (right knee) [device allergy] ([walking difficulty], [difficulty in standing], [difficulty sleeping], [muscle pain], [pain]).Thigh muscles were so weak [muscle weakness].Tired [tiredness].Horrible constipation [constipation].Hair fell out in the back and on the side [hair loss].Rash appeared at back [rash].Case narrative: initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5097747.This case involves an adult patient (gender: unknown) who experienced allergic reaction to the synvisc (right knee) (device allergy), thigh muscles were so weak, tired, horrible constipation, hair fell out in the back and on the side and rash appeared at back, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) in right knee (second injection).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.The patient was not allergic to eggs.At the time of the event, the patient had ongoing blood pressure high.On an unknown date in 2000, the patient received synvisc injections in both knees.The patient went to the doctor to get another injection in 2001.He refused to give mean injection then stating that synvisc was not a preventive medicine.The doctor asked to comeback to get injection when the knees were inflamed.On an unknown date in 2001, the patient went to the orthopedist to get a synvisc injection as both of knees were very swollen and inflamed.Doctor injected the patient bilaterally.The next day, on (b)(6) 2001, the patient's hair fell out in the back (alopecia) and on the side and a rash appeared on the back (rash).The patient did not associate these first symptoms with the synvisc shots.On an unknown date in 2001, the patient returned for second bilateral injection of synvisc.On an unknown date in 2001, the patient received second injection of synvisc (hylan g-f 20, sodium hyaluronate) in right knee via intra-articular route for swollen and inflamed knees (dose, frequency, lot - unknown).Information on batch number was requested.On same day, when the patient arrived home, the patient was tired (fatigue) and sore (pain) and laid down.When the awoke, the patient could not stand up (dysstasia).When the patient finally managed to get up, walking was greatly impaired (gait disturbance; caused disability/permanent damage).The patient was able to walk with the assistance of a crutch on thursday of that week (2001).The patient was not able to sleep because of having horrible muscle pain (myalgia) that kept the patient awake all night (insomnia).The patient saw doctor on the following monday.The doctor informed that the patient had an allergic reaction to the synvisc (device allergy).The doctor did not think the rash was associated with the synvisc.The patient made an appointment with a dermatologist who prescribed a steroidal cream.After using two tubes of the cream, the patient still had the rash.Most disturbing was ability to walk was greatly impaired.Also, thigh muscles were so weak (muscular weakness), it was difficult for the patient to walk upstairs- the patient had 27 steps from door to bedroom.The sunday before seeing the doctor, the patient had gone to the gym and gotten into the therapeutic pool and used the weights.The patient received some relief.The patient asked the doctor to prescribed physical therapy that had been of some relief.The patient had horrible constipation (constipation; latency: unknown).The patient could only have a bowel movement if use a laxative prior to this.The patient was regular, daily with the bowel movements.The doctor told that this would subside in three weeks.It had been almost two months and the patient was still having difficulty walking.The patient was afraid that will never regain ability to walk.The pain was excruciating, and the patient suffering sleep deprivation since the patient could not sleep at night (insomnia).The quality of life had suffered greatly as the patient could not go anywhere that required walking any distance.The patient had taken off work and holidays were miserable because of this.The patient wanted to know if there was any antidote or prescribed treatment for this.The patient had seen doctor twice since the incident and he just stated that it will wear off, but the patient was doubtful.The patient had been in physical therapy since about 2001.The patient's ability to stand up was still impaired.Final diagnosis was rash appeared at back, hair fell out in the back and on the side, horrible constipation, tired, thigh muscles were so weak and allergic reaction to the synvisc.Action taken: unknown for all the events.Corrective treatment: steroidal cream for rash appeared at back, laxative for horrible constipation; crutches and physical therapy for device allergy; physical therapy for thigh muscles were so weak and not reported for hair fell out in the back and on the side and tired.Outcome: not recovered / not resolved for rash appeared at back, could not stand up/ability to standup is still impaired, and for walking was greatly impaired; unknown for rest all events.Reporter causality: not related for rash appeared at back and hair fell out in the back and on the side.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; batch number: unknown; global ptc number: (b)(4).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 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 complaints as stated in (b)(4) "product event handling" to determine if a capa is required.Final investigation was completed on 21-jan-2021 additional information was received on 21-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

Event Description

Allergic reaction to the synvisc (right knee) [device allergy] ([walking difficulty], [difficulty in standing], [difficulty sleeping], [muscle pain], [pain]) both of knees were very swollen and inflamed [joint inflammation] ([swelling of r knee]) thigh muscles were so weak [muscle weakness] tired [tiredness] horrible constipation [constipation] hair fell out in the back and on the side [hair loss] rash appeared at back [rash].Case narrative: this case is deleted following an incorrect worldwide id.The new case (b)(4) will be submitted with the same information.This case is cross linked with case: (b)(4) (same patient; multiple devices).Initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5097747.This case involves an adult patient (gender: unknown) who experienced allergic reaction to the synvisc (right knee) (device allergy), thigh muscles were so weak, tired, horrible constipation, hair fell out in the back and on the side and rash appeared at back and both of knees were very swollen and inflamed after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) in right knee (second injection).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.The patient was not allergic to eggs.At the time of the event, the patient had ongoing blood pressure high.On an unknown date in 2000, the patient received synvisc injections in both knees.The patient went to the doctor to get another injection in 2001.He refused to give mean injection then stating that synvisc was not a preventive medicine.The doctor asked to comeback to get injection when the knees were inflamed.On an unknown date in 2001, the patient went to the orthopedist to get a synvisc injection as both of knees were very swollen and inflamed.Doctor injected the patient bilaterally.The next day, on (b)(6) 2001, the patient's hair fell out in the back (alopecia) and on the side and a rash appeared on the back (rash).The patient did not associate these first symptoms with the synvisc shots.On an unknown date in 2001, the patient returned for second bilateral injection of synvisc.On an unknown date in 2001, the patient received second injection of synvisc (hylan g-f 20, sodium hyaluronate) in right knee via intra-articular route for swollen and inflamed knees (dose, frequency, lot - unknown).Information on batch number was requested.On same day, when the patient arrived home, the patient was tired (fatigue) and sore (pain) and laid down.When the awoke, the patient could not stand up (dysstasia).When the patient finally managed to get up, walking was greatly impaired (gait disturbance; caused disability/permanent damage).The patient was able to walk with the assistance of a crutch on thursday of that week (2001).The patient was not able to sleep because of having horrible muscle pain (myalgia) that kept the patient awake all night (insomnia).The patient saw doctor on the following monday.The doctor informed that the patient had an allergic reaction to the synvisc (device allergy).The doctor did not think the rash was associated with the synvisc.The patient made an appointment with a dermatologist who prescribed a steroidal cream.After using two tubes of the cream, the patient still had the rash.Most disturbing was ability to walk was greatly impaired.Also, thigh muscles were so weak (muscular weakness), it was difficult for the patient to walk upstairs- the patient had 27 steps from door to bedroom.The sunday before seeing the doctor, the patient had gone to the gym and gotten into the therapeutic pool and used the weights.The patient received some relief.The patient asked the doctor to prescribed physical therapy that had been of some relief.The patient had horrible constipation (constipation; latency: unknown).The patient could only have a bowel movement if use a laxative prior to this.The patient was regular, daily with the bowel movements.The doctor told that that this would subside in three weeks.It had been almost two months and the patient was still having difficulty walking.The patient was afraid that will never regain ability to walk.The pain was excruciating, and the patient suffering sleep deprivation since the patient could not sleep at night (insomnia).The quality of life had suffered greatly as the patient could not go anywhere that required walking any distance.The patient had taken off work and holidays were miserable because of this.The patient wanted to know if there was any antidote or prescribed treatment for this.The patient had seen doctor twice since the incident and he just stated that it will wear off, but the patient was doubtful.The patient had been in physical therapy since about 2001.The patient's ability to stand up was still impaired.On the unknown date, after unknown latency of initiating the treatment with synvisc, patient experienced that knees were very swollen and inflamed (arthritis) and patient was afraid that patient would never regain ability to walk.Final diagnosis was rash appeared at back, hair fell out in the back and on the side, horrible constipation, tired, thigh muscles were so weak and allergic reaction to the synvisc.Action taken: unknown for all the events.Corrective treatment: steroidal cream for rash appeared at back, laxative for horrible constipation; crutches and physical therapy for device allergy; physical therapy for thigh muscles were so weak and not reported for hair fell out in the back and on the side and tired.Outcome: not recovered / not resolved for rash appeared at back, could not stand up/ability to standup is still impaired, and for walking was greatly impaired; unknown for rest all events.Reporter causality: not related for rash appeared at back and hair fell out in the back and on the side.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; batch number: unknown; global ptc number: (b)(4).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 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 complaints as stated in sop rdg-sop-000440 to determine if a capa is required.Final investigation was completed on 21-jan-2021.Additional information was received on 21-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.Additional information was received on 08-jan-2021 from the non-healthcare professional.Additional event of both of knees were very swollen and inflamed was added.Verbatim for walking was greatly impaired was updated to walking was greatly impaired/ still having difficulty walking.Related case id added.Clinical course updated and text amended accordingly.Follow up information received on 03-mar-2021 from other healthcare professional.No significant information.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11242121
• MDR Text Key: 233152381
• Report Number: 2246315-2021-00043
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability