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 Necrosis (1971); Pain (1994); Skin Discoloration (2074)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious event of necrosis at injection site was considered expected and possibly related to the treatment.Serious criteria include the need for medical intervention including antiplatelet therapy, vitamin c and soft paraffin ointment.The non-serious, expected event of pain at injection site and unexpected event of lividity were considered possibly related to the treatment.Potential etiologies include the patient's medical history of acc and cppd.The ifu includes information that durolane should be used with caution in patients with pre-existing chondrocalcinosis.Potential contributory factors include injection technique.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.Manufacturing narrative: the lot number was not reported.

Event Description

Case reference number (b)(4) is a literature report detected on (b)(6) 2020 during a weekly literature search.Desmottes m-c, delorme l, clay m, troussier b, leccia m-t.Skin necrosis following intra-articular hyaluronic acid injection in the knee of a 63-year-old male.Joint-bone-spine 2020;87(4):361-362.We report the case of a (b)(6) year-old male under our care for bilateral tricompartmental knee oa associated with articular chondrocalcinosis (acc).This former volleyball player underwent multiple glucocorticoid injections in both knees (2014, 2016, 2019).In (b)(6) 2019, he received an injection of ha (durolane) in both knees by the lateral infrapatellar route.Five days after this injection, the patient presented with a painful livedoid patch with several necrotic areas on the anterior part of his right knee.Laboratory work-up found no elevated acute phase reactants or coagulation disorder.Mri showed infiltration of the subcutaneous fatty tissue without fluid accumulation on the anteromedial side of the knee with isointense signal on t1-weighted sequences that increased after gadolinium injection.We made the clinical diagnosis of skin necrosis.The treatment we initiated consisted of antiplatelet therapy, vitamin c and soft paraffin ointment, which resulted in local resolution and pain reduction at 1 month.In the context of ha injection for oa, to our knowledge this is only the third case of skin necrosis described after an intra-articular injection.Our patient had advanced oa and cppd; several joint aspirations had previously collected serous and hemorrhagic fluid.It is possible that hypervascularization and synovial hypertrophy related to flares of cppd contributed to passage of the ha product into an artery.In general, whether the context is rheumatology or esthetics, the condition resolves favorably with the application of soft paraffin ointment and antiplatelet therapy.Nevertheless, complete healing may take more than 6 months because the ha breaks downs slowly.

• 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 ; 9615146
• MDR Report Key: 10245381
• MDR Text Key: 197970811
• Report Number: 9710154-2020-00061
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/08/2020
• 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): Required Intervention
• Patient Age: 63 YR