MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3507700BC
Medical Device Problem Codes	Material Rupture (1546); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.In addition, an anomaly was observed on the edges of the tear consistent with a crease/fold.The evaluation determined that the cause of the rupture is consistent with normal wear.The instructions for use state that ruptures can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following may cause implants to rupture: stressing the implant during implantation or other procedures and weakening it; folding or wrinkling of the implant shell.Breast implants may also wear over time.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Reason for device explant and/or reoperation: left sided rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old african american/native american female who underwent breast augmentation revision with a 550cc mentor memorygel breast implant experienced bilateral rupture post procedure.As a result, an explant was performed on (b)(6) 2021.The left sided rupture was reported initially under 1645337-2020-08062 on june 30, 2020.The device thought to be concomitant was returned and reported under 1645337-2020-08062 on october 27, 2021.On october 28, 2021, mentor received additional information that the device returned was in fact the right sided device.The additional information clarified that the explant was being performed due to left sided rupture, however, upon explant, the right side was also found to be damaged, and that the right implant was returned to mentor.This report relates to the right prosthesis.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12865985
• Report Number: 1645337-2021-13052
• Device Sequence Number: 5942784
• Product Code: FTR
• UDI-Device Identifier: 00081317000181
• UDI-Public: 00081317000181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2009
• Device Model Number: 3507700BC
• Device Catalogue Number: 3507700BC
• Device Lot Number: 5564705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2004
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, American Indian Or Alaskan Native