MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN 3.5MM HIGH OFFSET ASCEND FLEX TRAY; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 03/01/2024

Event Type  Injury  

Event Description

As reported: "revision was of a stryker reverse shoulder for instability.The 36mm glenosphere, 36 +6mm ascend flex humeral liner and 3.5mm high offset ascend flex tray were replaced with larger sizes to ensure stability.The event occurred on (b)(6) 2024.It is unknown when the patient first started experiencing the instability.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: UNKNOWN 3.5MM HIGH OFFSET ASCEND FLEX TRAY
• Type of Device: 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19005940
• MDR Text Key: 338933206
• Report Number: 3000931034-2024-00177
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention