MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 39MM 9TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF392B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that a revision surgery was scheduled, using the blueprint planning feature.The patient developed an infection, and the surgeon removed all implants, including tornier's flex stem and perform reverse glenoid systems, and replaced them with an antibiotic spacer.There were no complications in removing the implants and placing the antibiotic spacer.
Additional Manufacturer Narrative
The reported event was confirmed.Even though the device was not returned pathology from the reporter was provided that verified the presence of infection thru arthroscopic biopsy.Based on the investigation, the root cause could not be determined.The implant appeared to be properly seated in the provided x-ray's, and the bacteria identified in the infection is a common type typically associated with periprosthetic infections linked to skin preparation and contamination during the procedure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a revision surgery was scheduled, using the blueprint planning feature.The patient developed an infection, and the surgeon removed all implants, including tornier's flex stem and perform reverse glenoid systems, and replaced them with an antibiotic spacer.There were no complications in removing the implants and placing the antibiotic spacer.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 39MM 9TH B 12.5DG
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20397403
• Report Number: 3000931034-2024-00605
• Device Sequence Number: 3492964
• Product Code: KWS
• UDI-Device Identifier: 03700434020502
• UDI-Public: 03700434020502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: Lay User/Patient
• Device Expiration Date: 05/06/2024
• Device Catalogue Number: DWF392B
• Device Lot Number: 7517AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2019
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male