MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS LNG HUM PTC STEM 3B 132.5DG 98MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWF613B

Device Problem Biocompatibility (2886)

Patient Problems Ossification (1428); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 07/17/2023

Event Type  Injury  

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 disposition is unknown.

Event Description

The patient reported pain and decreased function, leading to a revision surgery.The reason for the revision surgery was listed as heterotopic ossification, severe stiffness, and nickel metal allergy.Components including the tray, insert, and glenosphere were explanted, while the stem, baseplate, and central screw were retained.The relatedness to the study device and the surgical procedure was assessed as possible.

• Brand Name: TORNIER FLEX SHOULDER SYS LNG HUM PTC STEM 3B 132.5DG 98MM
• 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: 18963718
• MDR Text Key: 338431046
• Report Number: 3000931034-2024-00122
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434021660
• UDI-Public: 03700434021660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

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: DWF613B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG