MAUDE Adverse Event Report: GALDERMA Q-MED AB DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Muscle Weakness (1967); Necrosis (1971); Neuropathy (1983); Pain (1994); Skin Discoloration (2074); Hypoesthesia (2352); Paresthesia (4421); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious events of embolism and injection site necrosis were considered expected and possibly related to the treatment.Serious criteria included other important medical events.The non-serious, expected event of injection site pain and the unexpected events of erythema, discolouration, paraesthesia and hypoaesthesia at the injection site, livedo reticularis, muscular weakness and mononeuropathy were considered possibly related to the treatment.The likely root cause for the events include intravascular injection leading to embolism, skin necrosis and its manifestations.Potential contributory factor include inadequate injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a nonconforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.

Event Description

Case reference number (b)(4) is a literature report detected on (b)(6) 2021.Berrios-hernandez et al.Dermal embolization associated with peroneal mononeuropathy: an unusual complication after hyaluronic acid intra-articular injections.International journal of dermatology 2020.Doi: 10.1111/ijd.15347.A (b)(6) woman with bilateral gonarthrosis ga had been treated for the last 6 years with biannual intra-articular ha infiltrations.Injections were made using a lateral suprapatellar approach.With the patient supine and the knee extended, an 18-gauge needle was positioned perpendicular to the skin on the suprapatellar bursa 1 cm above the proximal patellar margin.Twenty-four hours after the last bilateral infiltration, she complained of intense pain on the proximal surface of her left leg.Physical examination revealed an extensive, livedoid, erythematous lesio case reference number (b)(4) is a literature report detected on (b)(6) 2021.Berrios-hernandez et al.Dermal embolization associated with peroneal mononeuropathy: an unusual complication after hyaluronic acid intra-articular injections.International journal of dermatology 2020.Doi: 10.1111/ijd.15347.A (b)(6) woman with bilateral gonarthrosis ga had been treated for the last 6 years with biannual intra-articular ha infiltrations.Injections were made using a lateral suprapatellar approach.With the patient supine and the knee extended, an 18-gauge needle was positioned perpendicular to the skin on the suprapatellar bursa 1 cm above the proximal patellar margin.Twenty-four hours after the last bilateral infiltration, she complained of intense pain on the proximal surface of her left leg.Physical examination revealed an extensive, livedoid, erythematous lesion with some nonpalpable, purpuric areas.The patient was treated symptomatically with nonsteroidal anti-inflammatory drugs (nsaids), but 1 week later, the lesion persisted with associated paresthesia on the lower third of the leg and distal strength loss.Electromyography confirmed a mononeuropathy of the left peroneal nerve, with decreased nerve excitability and sensorial response, and denervation of the dependent musculature.The remaining values were within normal limits.A punch biopsy was taken, and histopathological examination revealed slightly basophilic, amorphous, intraluminal material in some small vessels located in the subcutaneous fat tissue as well as in the surrounding interstitium.It stained with alcian blue, and it failed to show refringence under polarized light.Thrombosis or inflammatory signs were not noted.In addition, there was mild dilatation of the superficial dermal vessels, some showing telangiectatic appearance with minimal lymphoid infiltrate.Findings were considered consistent with ha embolism, and symptomatic treatment with nsaids was continued.After 7 months, skin lesions had almost completely disappeared and muscular function returned to normal.Only mild hypoesthesia on the involved area persisted for 10 months.Our patient experienced a highly unusual complication of ha intra-articular injection, with livedo reticularis lesions, pain, and neuropathy, which started in the first 24 hours after the procedure.Skin biopsy demonstrated ha embolism in dermal vessels as the etiological factor.Only two similar cases are available in the literature, but this is the first patient with associated neuropathy.It is reasonable to admit that neural damage is related to the involvement of vasa nervorum by ha embolism, similar to that demonstrated in skin vessels.Spontaneous resolution of the cutaneous lesions in parallel to neural function recovery without specific treatment also favors considering ha as the only cause of the patient's complications, for it is expected ha to be reabsorbed in about 6 months.This complication is likely associated with incorrect injection technique: hyaluronic acid was either injected into the wrong anatomic site or it leaked from the joint due to direct injury with subsequent embolization.Histopathologically, ha is seen in the dermis as basophilic amorphous material which stains positively for alcian blue but is negative when examined under polarized light, features present in our case, and the diagnosis of ha embolism was made according to this finding and the clinical context.Differential diagnosis includes other causes of cutaneous embolism, atrial myxoma material being the main consideration.In this condition, myxoid, basophilic material occluding cutaneous arterioles is also found, and attention must be paid to the presence of delicate stellate fibroblasts as a clue to the real nature of the material.In doubtful situations, clinicopathological correlation will resolve the problem in most cases.Treatment of ha embolization is controversial, and experience is lacking in cases following intra-articular injection but in the three cases available, lesions resolved without specific treatment in 4-6 months n with some nonpalpable, purpuric areas.The patient was treated symptomatically with nonsteroidal anti-inflammatory drugs (nsaids), but 1 week later, the lesion persisted with associated paresthesia on the lower third of the leg and distal strength loss.Electromyography confirmed a mononeuropathy of the left peroneal nerve, with decreased nerve excitability and sensorial response, and denervation of the dependent musculature.The remaining values were within normal limits.A punch biopsy was taken, and histopathological examination revealed slightly basophilic, amorphous, intraluminal material in some small vessels located in the subcutaneous fat tissue as well as in the surrounding interstitium.It stained with alcian blue, and it failed to show refringence under polarized light.Thrombosis or inflammatory signs were not noted.In addition, there was mild dilatation of the superficial dermal vessels, some showing telangiectatic appearance with minimal lymphoid infiltrate.Findings were considered consistent with ha embolism, and symptomatic treatment with nsaids was continued.After 7 months, skin lesions had almost completely disappeared and muscular function returned to normal.Only mild hypoesthesia on the involved area persisted for 10 months.Our patient experienced a highly unusual complication of ha intra-articular injection, with livedo reticularis lesions, pain, and neuropathy, which started in the first 24 hours after the procedure.Skin biopsy demonstrated ha embolism in dermal vessels as the etiological factor.Only two similar cases are available in the literature, but this is the first patient with associated neuropathy.It is reasonable to admit that neural damage is related to the involvement of vasa nervorum by ha embolism, similar to that demonstrated in skin vessels.Spontaneous resolution of the cutaneous lesions in parallel to neural function recovery without specific treatment also favors considering ha as the only cause of the patient's complications, for it is expected ha to be reabsorbed in about 6 months.This complication is likely associated with incorrect injection technique: hyaluronic acid was either injected into the wrong anatomic site or it leaked from the joint due to direct injury with subsequent embolization.Histopathologically, ha is seen in the dermis as basophilic amorphous material which stains positively for alcian blue but is negative when examined under polarized light, features present in our case, and the diagnosis of ha embolism was made according to this finding and the clinical context.Differential diagnosis includes other causes of cutaneous embolism, atrial myxoma material being the main consideration.In this condition, myxoid, basophilic material occluding cutaneous arterioles is also found, and attention must be paid to the presence of delicate stellate fibroblasts as a clue to the real nature of the material.In doubtful situations, clinicopathological correlation will resolve the problem in most cases.Treatment of ha embolization is controversial, and experience is lacking in cases following intra-articular injection but in the three cases available, lesions resolved without specific treatment in 4-6 months.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 11542898
• MDR Text Key: 250847961
• Report Number: 9710154-2021-00017
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR