MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6B 132.5DG 86MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF606B
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that: "an implant that was no longer sterile was inadvertently installed.This was noticed after the operation.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the information provided, reported expiration date - implantation date.A device inspection was not possible since the affected device was implanted.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling indicates as follows: an implant whose packaging is open or damaged or whose expiration date has passed must not be used.Based on investigation, the root cause was attributed to a user related issue (off-label use).An nc has been opened by the affected local german stryker to investigate further (expired implant in consignment stock).If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that: "an implant that was no longer sterile was inadvertently installed.This was noticed after the operation.".

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6B 132.5DG 86MM
• 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 S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22202592
• Report Number: 3000931034-2025-00315
• Device Sequence Number: 7667387
• Product Code: KWS
• UDI-Device Identifier: 03700434019063
• UDI-Public: (01)03700434019063(11)200123(17)250123(21)CZ4120006011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2025
• Device Catalogue Number: DWF606B
• Device Lot Number: CZ4120006
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2020
• 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
• Patient Sex: Unknown