MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE MM+ 525CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341405
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: rupture.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female who underwent primary breast augmentation with a mentor memoryshape 525cc silicone prosthesis experienced right sided rupture post procedure.An mri examination was performed and rupture was diagnosed.As a result, an explant was performed on (b)(6) 2020.
Additional Manufacturer Narrative
On october 12 2020, additional information received indicated that the patient underwent bilateral replacements with mentor silicone implants.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 27, 2020: the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Additional information received indicated that the patient underwent bilateral replacements with mentor silicone implants.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2020: during the visual evaluation, the device was observed to be ruptured.Additionally, an anomaly was observed within the tear consistent with shell wear.The evaluation determined that the loss of shell integrity is consistent with a rupture caused by wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE MM+ 525CC
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10643840
• Report Number: 1645337-2020-12713
• Device Sequence Number: 2969149
• Product Code: FTR
• UDI-Device Identifier: 00081317005360
• UDI-Public: 00081317005360
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2020
• Device Model Number: 3341405
• Device Catalogue Number: 3341405
• Device Lot Number: 6896246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 10/27/2020; 11/11/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/26/2020; 11/03/2020; 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR