MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) HYLAN G-F 20 (SYNVISC); INTRA-ARTICULAR HYALURONIC ACID

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was received on (b)(6) 2015 via a literature article: kim wb, alhusayen ro.Skin necrosis from intra-articular hyaluronic acid injection.Journal of cutaneous medicine and surgery.2015 mar/apr;19(2):182-184.Doi 10.2310/7750.2014.14081 this case concerns a (b)(6) old male patient who started treatment with synvisc (hylan g-f 20) and developed cutaneous necrosis.No medical history, past drugs, concurrent conditions and concomitant medications were reported.On an unknown date, the patient initiated treatment with intra-articular synvisc injection (dose, frequency, batch/lot number and expiration date: not provided) for knee osteoarthritis in both knees.On an unknown date, 48 hours after a bilateral knee injection, the patient had painful skin eruption over the right knee.On examination, there was a welldemarcated, livedoid (net-like), violaceous patch on the right knee with a dark center and a lighter border.The left knee was normal.A punch biopsy of the skin was performed and showed atrophic epidermis with patchy necrosis.The viable portions of the epidermis revealed reactive keratinocytes admixed with scattered necrotic keratinocytes.In the dermis, there was an amorphous basophilic foreign material consistent with synvisc present within both the dermal stroma and a medium-sized vein with an associated thrombus forming.Hence, the histologic findings were consistent with tissue necrosis due to injection entering the cutaneous vasculature.The patient was treated conservatively with topical fusidic acid dressings.The lesion resolved in 4 months' time.Action taken: unknown outcome: recovered/ resolved reporter causality: skin necrosis from intra-articular hyaluronic acid seriousness criteria: important medical event pharmacovigilance comment: sanofi company comment dated (b)(6) 2015: this case concerns a male patient receiving treatment with synvisc injection for osteoarthritis of the knee.Later the patient developed cutaneous necrosis.The causal role of the drug cannot be denied due to the significant temporal relationship between the drug and the occurrence of the event.However, as reported the event occurred due to the leakage of drug into the cutaneous vasculature whereas the injection is for intra-articular use and thus signifying the need for better procedural techniques when using the device.

Event Description

This unsolicited device case from (b)(6) was received on 28-sep-2015 via a literature article: kim wb, alhusayen ro.Skin necrosis from intra-articular hyaluronic acid injection.Journal of cutaneous medicine and surgery.2015 mar/apr; 19 (2):182-184.Doi 10.2310/7750.2014.14081.This case concerns a (b)(6) male patient who started treatment with synvisc (hylan g-f 20) and developed cutaneous necrosis.No medical history, past drugs, concurrent conditions and concomitant medications were reported.On an unknown date, the patient initiated treatment with intra-articular synvisc injection (dose, frequency, batch/lot number and expiration date: not provided) for knee osteoarthritis in both knees.On an unknown date, 48 hours after a bilateral knee injection, the patient had painful skin eruption over the right knee.On examination, there was a well demarcated, livedoid (net-like), violaceous patch on the right knee with a dark center and a lighter border.The left knee was normal.A punch biopsy of the skin was performed and showed atrophic epidermis with patchy necrosis.The viable portions of the epidermis revealed reactive keratinocytes admixed with scattered necrotic keratinocytes.In the dermis, there was an amorphous basophilic foreign material consistent with synvisc present within both the dermal stroma and a medium-sized vein with an associated thrombus forming.Hence, the histologic findings were consistent with tissue necrosis due to injection entering the cutaneous vasculature.The patient was treated conservatively with topical fusidic acid dressings.The lesion resolved in 4 months' time.Action taken: unknown.Outcome: recovered/ resolved.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: 39481.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 was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: skin necrosis from intra-articular hyaluronic acid seriousness criteria: important medical event additional information was received on 02-oct-2015.Ptc results were added and the text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 06-oct-2015: the follow-up information received does not change the prior assessment of the case.Sanofi company comment dated 01-oct-2015: this case concerns a male patient receiving treatment with synvisc injection for osteoarthritis of the knee.Later the patient developed cutaneous necrosis.The causal role of the drug cannot be denied due to the significant temporal relationship between the drug and the occurrence of the event.However, as reported the event occurred due to the leakage of drug into the cutaneous vasculature whereas the injection is for intra-articular use and thus signifying the need for better procedural techniques when using the device.

• Brand Name: HYLAN G-F 20 (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5127101
• MDR Text Key: 27433332
• Report Number: 2246315-2015-98570
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• 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?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR