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

Model Number	THPX620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Crushing Injury (1797); Breast Discomfort/Pain (4504)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient who had a 620cc mentor memorygel xtra breast implant experienced rupture of an unknown side post procedure.The rupture was noted shortly after a car accident.Breast pain was also present.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Because the side of the rupture could not be determined, it could not be determined which of the two lot and serial numbers provided belongs to the ruptured implant.Section d has been updated to reflect that.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 for the finished device number 7592932, and no non-conformances related to the reported complaint were identified.Manufacturing date: aug/10/2018.Sterilization expiration date: aug/09/2023.A manufacturing record evaluation was performed for the finished device 7657226 number, and no non-conformances were identified.Manufacturing date: dec/05/2028.Expiration date: dec/02/2023.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14983156
• Report Number: 1645337-2022-08111
• Device Sequence Number: 12017477
• Product Code: FTR
• UDI-Device Identifier: 00081317025771
• UDI-Public: 00081317025771
• 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: 2019
• 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 Model Number: THPX620
• Device Catalogue Number: THPX620
• Device Lot Number: 7592932, 7657226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female