MAUDE Adverse Event Report: FIDIA FARMACEUTICI S.P.A. HYALURONIC ACID; SODIUM HYALURONATE

Catalog Number 89122-0724-20

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

Patient Problems Embolism (1829); Muscle Weakness (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Skin Discoloration (2074); Vasodilatation (2127); Hypoesthesia (2352); Paresthesia (4421); Localized Skin Lesion (4542); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This serious case was detected in the medical literature on 16-dec-2020 from "berríos-hernández, m., casas-fernández, l., blanco-rodríguez, j.And suárez-peñaranda, j.M.(2020), dermal embolization associated with peroneal mononeuropathy: an unusual complication after hyaluronic acid intra-articular injections.Int j dermatol.Https://doi.Org/10.1111/ijd.15347".This spontaneous case was reported in the medical literature by a physician from spain and concerns a (b)(6)-year-old female patient who developed therapeutic embolization, livedo reticularis, leg pain and peroneal nerve injury following intra-articular injection of hyaluronic acid for gonarthrosis.A (b)(6)-year-old woman with bilateral 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.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.

Event Description

This serious case was detected in the medical literature on 16-dec-2020 from "berríos-hernández, m., casas-fernández, l., blanco-rodríguez, j.And suárez-peñaranda, j.M.(2020), dermal embolization associated with peroneal mononeuropathy: an unusual complication after hyaluronic acid intra-articular injections.Int j dermatol.Https://doi.Org/10.1111/ijd.15347".This spontaneous case was reported in the medical literature by a physician from spain and concerns a 72-year-old femal patient who developed therapeutic embolization, livedo reticularis, leg pain and peroneal nerve injury following intra-articular injection of hyaluronic acid for gonarthrosis.A 72-year-old woman with bilateral 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.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.

Manufacturer Narrative

After follow-up request to the author it was discovered that the suspected product was durolane.Thus, fidia's product involvement can be excluded.The case is nullified in the internal database for consistency, but the case is still available for consultation.No further information is available.

• Brand Name: HYALURONIC ACID
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): FIDIA FARMACEUTICI S.P.A.; via ponte della fabbrica, 3/a; abano terme 35031
• MDR Report Key: 11154384
• MDR Text Key: 226292999
• Report Number: 9610200-2021-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• PMA/PMN Number: P950027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 89122-0724-20
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR