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

Catalog Number	SMPX755
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930); Seroma (2069)
Date of Event	03/25/2019
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: right side capsular contracture; baker grade iv.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent primary breast augmentation with a 755cc mentor memorygel, breast implant and was presented with capsular contracture; baker grade iv on her right side postoperatively.As a result, patient underwent explantation and replacement on (b)(6) 2019 with catalog number smpx-755 and serial number (b)(4) on the right side.
Additional Manufacturer Narrative
On 5/28/2019, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 6/4/2019, mentor became aware that patient encountered early onset seroma as well.Hence, patient code seroma has been added to this report.On 6/24/2019, mentor became aware that the patient's ethnicity and race is caucasian /white, procedure performed was "primary breast reconstruction." date of explant was updated to (b)(6) 2019 as per information received.Also, code "infection" was added per additional information received.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 8578241
• Report Number: 3006942524-2019-00508
• Device Sequence Number: 11179171
• Product Code: FTR
• UDI-Device Identifier: 00081317025177
• UDI-Public: 00081317025177
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Catalogue Number: SMPX755
• Device Lot Number: 7633400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 06/04/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/04/2019; 07/01/2019
• 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: 57 YR