MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS LNG HUM CMT STEM 2B 132DG 88MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER ADDITIVE, CEMENTED

Catalog Number	DWF712B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Limb Fracture (4518)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that a revision surgery took place due to a fractured humerus at the level of the distal ascend flex stem.It was a periprosthetic humeral shaft fracture in a female patient with ra.Only the humeral components were removed at the first revision.The primary glenoid implants were left in place.
Event or Problem Description
It was reported that a revision surgery took place due to a fractured humerus at the level of the distal ascend flex stem.It was a periprosthetic humeral shaft fracture in a female patient with ra.Only the humeral components were removed at the first revision.The primary glenoid implants were left in place.
Additional Manufacturer Narrative
Correction : d6 date of implant.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.The opinion of the medical expert was requested on this case despite the limited information provided, and stated as following: this event ¿is most likely due to very poor bone quality and possibly due to infection" (rheumatoid arthritis, combined with female sex and age).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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS LNG HUM CMT STEM 2B 132DG 88MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER ADDITIVE, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19187881
• Report Number: 3000931034-2024-00268
• Device Sequence Number: 17966625
• Product Code: KWS
• UDI-Device Identifier: 03700434022391
• UDI-Public: 03700434022391
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 12/08/2023
• Device Catalogue Number: DWF712B
• Device Lot Number: AC2261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2018
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 50 KG