MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda, as the event migration (pt: device dislocation), was deemed to meet the serious criteria of required intervention to prevent permanent damage and due to disability or permanent damage.The device history record for radiesse injectable implant, lot number 100124807, was reviewed.A lot search was conducted on the reported lot and no other similar events were noted.The reported lot contains nonconformance reports, but none that would have contributed to this event.
Event or Problem Description
This mdr is related to mdrs 3013840437-2023-00094, 3013840437-2023-00096, and 3013840437-2023-00097, referring to the same patient.This case was linked to lssmv case numbers (b)(4) and (b)(4), referring to the same reporter and same patient, and to case number (b)(4) referring to the same reporter.This spontaneous report was received from a us physician and concerns a female patient.She was injected with radiesse.The physician contacted with the patient recently prior to this report who moved in 2020.She was injected before she moved.After the radiesse injection, the patient was experiencing a delayed allergic reaction.She was working with a plastic surgeon who was dealing with more than her case alone (as reported).The outcome of the event was unknown.Follow-up information was received on 17-aug-2023: this case was upgraded to serious.The events migration, scarring and calcification, off label use and product preparation issue were added.The verbatim delayed allergic reaction was amended to delayed allergic reaction/immune mediated delayed hypersensitivity, coding remains unchanged.The linking sentence was added.The patients initials, age and date of birth were provided.She was 50 years old at the time of the event (ambiguously reported as 54 years old).She was injected with a total of 3 ml of radiesse into the lateral cheekbones and angle of jaw (off label use of device), on (b)(6) 2020.Batch number was reported as 100124807.The batch record review was received and the lot number for radiesse was confirmed as 100124807 (expiry date 10/2022).A lot search in the global safety database was conducted.Radiesse was diluted with a total of 0.6 ml of bacteriostatic normal saline (product preparation issue), and injected with 2 syringes.The physician kept the treatment area clean.There were no post-injection issues.The patient was previously treated with juvederm into the lips, on (b)(6) 2012 (1 syringe), with juvederm into the mostly lips, perioral and some lateral cheekbone, on (b)(6) 2014 (2 syringes), with restylane silk, into the lips and perioral, on (b)(6) 2015 (1 syringe) and with volbella, into the wrinkles, lines in lips, perioral, periorbital and glabellar areas, on (b)(6) 2017 (3 syringes).She was previously injected with a total of 3 ml of radiesse(+), for dorsum of hands, on (b)(6) 2017.Batch number was reported as 100093103.She was injected with 2 syringes.Radiesse(+) was diluted with a total of 3 ml of bacteriostatic normal saline.In 2017, the patient experienced left hand swelling and infected.On (b)(6) 2017, she wrote an email that she was distraught over her dog being sick and she took amoxicillin (reported as amoxacillin) for sinus infection for 10 days but it did not help the hand.The physician spoke with her over the phone and she stated that her skin on the hand was irritated.The patient was not able to tell whether the problem was on the skin or below the skin.She was not able to come in that day so the physician called in antibiotics for her and asked her to follow up as soon as possible.On (b)(6) 2017, at the office visit it was unclear if problem with left hand started because she was so distraught over her dog dying/emergency room/intensive care unit trips.The left hand was swollen with slight redness over the fourth metacarpal area.There was no warmth or streaking.The physician broadened her antibiotic cover.On (b)(6) 2017 and (b)(6)2017, at the office visits, overall her hand swelling/redness was improving and antibiotic treatment continued.On (b)(6) 2017, at the office visit it looked mostly resolved, slight persistent swelling over the fourth metacarpophalangeal area.The patient received instructions to finish out the antibiotics.She was busy and instructed to call or email a follow-up.After her initial injection of radiesse(+) in the hands, she reported skin irritation which perhaps indicated an early infection.She was with antibiotics and her symptoms resolved.She was previously also injected with a total of 3 ml of radiesse(+) into the midface and a little chin, on (b)(6) 2019.Batch number was reported as 100110733.She was injected with 2 syringes.Radiesse(+) was diluted with a total of 2 ml of bacteriostatic normal saline.There were no post-injection issues.The reporter was not aware of any allergies or medications at the time the patient was treated with radiesse.The patients medical history included allergy to dust, pollen, nickel and metals.This was recorded over phone on (b)(6) 2021.The physician records also indicate that she had sinus issues that pre-dated the injection of radiesse into her midface.In (b)(6) 2020, the patient moved.On (b)(6) 2021, the patient left a message on the office phone of a possible sinus infection and asked for z-pak.The physician called her back and she told that she had not found a primary care physician (pcp) at that point and was scared of going to the urgent care or emergency room (er) for fear of getting covid.The physician told her that one course of z-pak was allowed but did not want to prescribe further antibiotics for her.If she did not get better, she needed to find a physician and be evaluated.On (b)(6) 2022, the patient stated that she was going back to her ear nose throat (ent) that monday and was hoping to get shot of antibiotics since this lingered for so long and was not seemed to be getting addressed with oral meds.On (b)(6) 2022, the patient emailed the physician and had not mentioned of any serious issues on the face.Her new dermatologist wanted to know what fillers she had done.On (b)(6) 2023, the patient send an email in which she recounted her health and facial inflammation travails.She stated, when she moved in the late fall of 2020, she was not able to figure out why her health drastically plummeted downwards.However, based on her email communications in (b)(6) 2021, (b)(6) 2022, and (b)(6) 2022, there was no indication that she was having significant face issues.This delay in her symptoms manifesting was of interest, suggesting a potential environmental trigger she encountered and possibly worse pollution or covid and/or the vaccine.In the same email she described tests and results.She visited an ear nose throat (ent) physician and was told that her nasal area was so inflamed they were not able to get a camera up her nose and was treated with massive amounts of more antibiotics and steroids.Covid tests were negative.Computer tomography (ct) scan showed massive inflammation, scarring and blockages in her nasal/cheek area.She later discovered the ct reviewer handwritten notes that were never shared with her.It was noted that she had severe scarring and calcification from chronic cosmetic filler injections.The patient sent a photo of one larger clump and 3 small bits of radiesse surgically removed from her face.The reporter did not know if the diagnosis of radiesse was made clinically or histologically.Based on the patients account, the treatment was necessary to accelerate recovery and to prevent more permanent damage.The timeline of the complications suggest an immune-mediated delayed hypersensitivity and filler migration.Since she moved in (b)(6) 2020 and started manifesting symptoms in the within the first year, there seemed to be a little discrepancy in the timeline.It was difficult to tease out what was the immune triggering event.It was perhaps a bacterial contamination from the october injection but even mundane things like local trauma, dental cleanings, flu-like illness or gastro intestinal upset was possible to heighten the immune status.Covid was raging at this time, and vaccine administration against the virus were also implicated.The physician was never made aware of such severe allergic reactions to the point of scarring it was awful for the physician to read from the patient account of her struggles with endless physicians appointments, repeated injections to dissolve radiesse, surgeries to remove radiesse from her face, and having to look at her face daily.The outcome of the event delayed allergic reaction was reported as not resolved (changed from unknown).The outcome of the remaining events was reported as not resolved.In the opinion of the reporter, a complex interplay of genetic predisposition and some environmental trigger unleashed this inflammatory cascade resulting in calcification and scarring.The fact that her health deteriorated after she moved was of significance.Air pollution was rated high in the place she moved and low in the place she lived.Drinking water quality was also lower in the place she moved.Therefore, an exposure to increased load of location-specific environmental toxins like benzene byproducts was not ruled out.It sounded like she had her baseline sinus problems.It was not until she moved that her symptoms manifested more severely.This timeline prompted the physician to think about the complex interplay of genetics and environmental factors playing out on the patients face.She perhaps had pro-inflammatory and detox mutations since her symptoms manifested after she moved, it made the physician wonder whether the increased environmental toxin load was too much for her body to clear, unleashing the detrimental inflammatory cascade.If the patients scarring was the result of bacterial contamination issue, the physician was shocked that there were not more widespread scarring problems.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 17673877
• Report Number: 3013840437-2023-00095
• Device Sequence Number: 12390265
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3221014100124807U
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2022
• Device Catalogue Number: 8071M0K2
• Device Lot Number: 100124807
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/01/2023
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT DRUG NOT AVAILABLE.
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female