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

Model Number	TMPX295
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/29/2020
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.On 3/29/2021, mentor received a photo of the device.A manufacturing record evaluation was performed for the finished device 7559857 number, and no non-conformances were identified.On 4/12/2021, upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: early onset seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast implantation procedure with a mentor memorygel xtra breast implant 295cc and suffered from an early onset seroma on the left side.As a result, the patient had undergone removal on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 2021, 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.In addition, the patient¿s initials were kmh, the date of birth was (b)(6) 1977, the replacement device is mentor memorygel xtra breast implant 295cc.The procedure was an augmentation revision.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor conducted a visual inspection of the returned device.During the visual evaluation of the siltex mod+prof xtra 295cc, a tear was observed in the anterior view measuring approximately 1.8 cm.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that section d3 manufacturer zip code was reported incorrectly.The actual zip code is (b)(6).Manufacturer¿s reference number: (b)(4).The actual zip code is (b)(6).

• 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 92618
• MDR Report Key: 11658177
• Report Number: 3006942524-2021-00006
• Device Sequence Number: 14509393
• Product Code: FTR
• UDI-Device Identifier: 00081317025450
• UDI-Public: 00081317025450
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2021

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: 04/04/2023
• Device Model Number: TMPX295
• Device Catalogue Number: TMPX295
• Device Lot Number: 7559857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/19/2021; 05/06/2021; 06/01/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/19/2021; 05/20/2021; 06/03/2021
• 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: 44 YR