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 DWF361B

Device Problem Unstable (1667)

Patient Problems Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device is retained by surgeon.

Event Description

As reported: "primary reverse shoulder arthroplasty, (b)(6),2023.Patient complained of occasional instability, discomfort on movement, of this shoulder joint, over many months.Surgeon concluded, due to patient undergoing multiple operations on this shoulder, including cuff repair, that the patient has a soft tissue envelope instability.Decision made by surgeon to increase glenosphere size, and implant a more constrained poly liner.This was performed, and range of motion on reduction was acceptable, and joint found to be stable.All other primary implants left insitu.Hence, only 3 x prosthesis exchanged - reverse tray, poly insert and glenosphere.Shoulder joint stable at conclusion of procedure.".

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DG
• 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: 19076081
• MDR Text Key: 339773847
• Report Number: 3000931034-2024-00201
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434020861
• UDI-Public: 03700434020861
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190521
• 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: 04/09/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWF361B
• Device Lot Number: AE8868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR
• Patient Sex: Female