MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF364B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In the tornier shoulder outcomes study, a traumatic acromial fracture occurred postoperatively.The adverse event resolved without sequelae.It was assessed as not related to the study device or the surgical procedure.An update noted that no action was taken, and no treatment was administered.During the visit, glenoid notching was observed, with the notch extending to the lower screw and glenoid lucencies involving the baseplate (superior or inferior).
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
Correction: g1 manufacturing site for devices.The reported event was not 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 (remained implanted).The opinion of the medical expert was requested on this case despite the limited information provided, and stated as following: "the high age of the patient and a trauma are sufficient to fracture an acromion.The fact that it healed without intervention shows there is not an abnormal stress on the acromion.The radiographic finding of notching, involving the inferior peripheral screw may be caused by several factors (glenoid placement, nsa angle of the humeral component, and individual shoulder use by the patient).Without any further information, this radiographic finding cannot be assessed".A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
In the tornier shoulder outcomes study, a traumatic acromial fracture occurred postoperatively.The adverse event resolved without sequelae.It was assessed as not related to the study device or the surgical procedure.An update noted that no action was taken, and no treatment was administered.During the visit, glenoid notching was observed, with the notch extending to the lower screw and glenoid lucencies involving the baseplate (superior or inferior).

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork 38330 ; EI 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18969299
• Report Number: 3000931034-2024-00139
• Device Sequence Number: 17695587
• Product Code: KWS
• UDI-Device Identifier: 03700434022612
• UDI-Public: 03700434022612
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Catalogue Number: DWF364B
• Device Lot Number: UNKNOWN
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG