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

Catalog Number	3341107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Autoimmune Disorder (1732)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant state: (b)(6).Complainant country: japan.Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: ¿ no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 2l03714 was manufactured on 07/dec/2022, in mlk-3 line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 16/feb/2024, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material identification (id) 1670079 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi) and recorded.Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on 16/feb/2024, complaints investigator ran a query in database in order to verify the complaints reported for the 2l03714 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect and as result an additional type 2 complaint was identified during this search as per work instruction (wi).Historical nonconformance review: on 16/feb/2024, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect for the lot number 2l03714 and as result, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: tm-002 m8 "visual inspection": ¿ frequency: 10 pouches per hour (80 pouches per turn) ¿ sample quantity: 80 pouches per turn ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 1 defective parts confirmed to date from a lot size 13560 products.This represents a defect rate of only 0.007%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 1.0% based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find a single defective pouch, which confirms that the lot is unlikely to breach an aql of 1.0.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record for lot 2l03714 showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No changes to the end-to-end manufacturing process or components used during assembly of the batch were made.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect.No additional complaints were reported for lot affected related to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ defect.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products are impacted, and the issue appears to be isolated.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092, manufacturing site: 9618003.
Event or Problem Description
It was reported that a patient implanted with two 225cc mentor memoryshape breast implant experienced symptoms including arthritis, pain, dry eyes, dry mouth post-operatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

• 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18818303
• Report Number: 1645337-2024-02609
• Device Sequence Number: 4289498
• Product Code: FTR
• UDI-Device Identifier: 00081317004912
• UDI-Public: 00081317004912
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 3341107
• Device Lot Number: 6995285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2015
• 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
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White