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

Catalog Number	3541108
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the returned device was completed by the failure analysis lab on 6/25/2019.Device evaluation summary: during evaluation of the sample it was observed to be intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No other anomalies were discovered.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some breast and/or chest pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.No further investigation will be conducted on this complaint at the moment.The reported complaint could not be confirmed.This report is not intended to deny that patients experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device 6800286 number, and no non-conformances were identified.This report contains supplemental information for mentor asr/psr reference number (b)(4).This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.Reason for device explant and/or reoperation: pain.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent breast surgery with 225cc mentor memoryshape breast implant.Now this patient presented with right breast implant rupture confirmed by ultrasound.The patient complained of sharp right breast pain in the upper right quadrant of the breast.Upon replacement surgery on (b)(6) 2019, the right implant was found to be intact.However, two distinct creases were found.The device was replaced with a 215cc mentor memoryshape breast implant.This report contains supplemental information for mentor asr/psr reference number (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• 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: 9207848
• Report Number: 1645337-2019-21249
• Device Sequence Number: 409871
• Product Code: FTR
• UDI-Device Identifier: 00081317005438
• UDI-Public: 00081317005438
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 02/28/2019
• Device Catalogue Number: 3541108
• Device Lot Number: 6800286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 10/18/2019
• 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: 53 YR