MAUDE Adverse Event Report: SEIKAGAKU CORPORATION VISCO-3; BIOLOGICS

Catalog Number 00111100103

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the patient had 3 visco-3 injections which caused body rash & itching. the patient was diagnosed with contact dermatitis via biopsy four months post-injection and treated by a dermatologist. no additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly. zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6-component code- suggested code: mechanical (g04) - provisional bottom.Visually verified item lot combination and reviewed manufacturing date as tasp exhibits signs of repeated use (nicks, gouges) and the post feature has fractured off, not all pieces returned.The device history records & receiving inspection report were reviewed for deviations and / or anomalies with no deviations / anomalies identified.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.Fractured tasps were analyzed by optical microscopy revealing hackle marks and river lines in the case of bending overload; and hackle marks, river lines and striations were found in the case of low cycle fatigue culminating in a bending overload failure type.Complaint is confirmed via product return & evaluation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VISCO-3
• Type of Device: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 17879349
• MDR Text Key: 325034852
• Report Number: 1822565-2023-02758
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 00111100103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female