MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3A 127.5DG 74MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF603A
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	05/12/2021
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.H3 other text : the device remains implanted in the patient.
Event or Problem Description
The patient underwent a total left shoulder replacement and later experienced weakness in the left shoulder.Diagnostic tests were conducted to determine the cause.Following consultation with a new physician, it was determined that a new glenoid head was needed.The patient is scheduled for revision surgery at stanford hospital.Additionally, the surgeon informed the patient that implanted parts will no longer be provided to patients.Despite this, the patient confirmed their scheduled revision surgery.The patient is reporting pain as well as weakness in the shoulder.
Additional Manufacturer Narrative
Corrections: h6 device code; g1 manufacturing site.The reported event was confirmed, based on the evaluation done by hcp on provided x-ray images and operative notes.The device inspection was not possible as the product was not returned for investigation.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, design & manufacturing related problems were found during the investigation.A review of the labelling indicates that the combinations of components: the tornier flex shoulder system in reversed configuration must be used in association with the aequalis reversed, aequalis reversed ii glenoid implant or tornier perform reversed augmented glenoid system.The tornier flex shoulder system in anatomic configuration must be associated with the tornier perform anatomic glenoid, tornier perform anatomic augmented glenoid or affiniti anatomic glenoid in case of total shoulder arthroplasty.Use of device from other manufactures is not recommended.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿yes, the off-label use is confirmed by the x-rays and supported by the surgical report.No adverse event regarding the tornier humeral or the humeral head.The implant used is indeed a shoulder innovations flat-back inset polyethylene glenoid implant.The imprint in the bone corresponds with the shape of the implant as well.During revision obviously on the glenoid component has been revised, the tornier stem was left in place.All components on the humeral side were well-assembled and the stem was well fixed in the humeral bone.¿ based on investigation, the root cause was attributed to a off-label use related issue.The failure was caused as patient was implanted with a tornier humeral head and stem and a other manufacturer glenoid poly device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The patient underwent a total left shoulder replacement and later experienced weakness in the left shoulder.Diagnostic tests were conducted to determine the cause.Following consultation with a new physician, it was determined that a new glenoid head was needed.The patient is scheduled for revision surgery at stanford hospital.Additionally, the surgeon informed the patient that implanted parts will no longer be provided to patients.Despite this, the patient confirmed their scheduled revision surgery.The patient is reporting pain as well as weakness in the shoulder.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3A 127.5DG 74MM
• 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: 18944231
• Report Number: 3000931034-2024-00120
• Device Sequence Number: 8204178
• Product Code: KWS
• UDI-Device Identifier: 03700434022599
• UDI-Public: 03700434022599
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2025
• Device Catalogue Number: DWF603A
• Device Lot Number: CZ5220297003
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG