MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET; SHOULDER JOINT METAL PROSTHESIS

Model Number DWF520

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Muscle Weakness (1967); Implant Pain (4561)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported that patient (b)(6) underwent a revision surgery seven years after primary study surgery due to instability/dislocation."there was also loosening of the prosthesis, rotator cuff insufficiency, poly wear, and the patient had pain." "aequalis reversed ii glenosphere was removed, as well as aequalis ascend flex reversed insert and tray.Insert was replaced to 42+9a; the tray was replaced to a high+0." the aequalis ascend flex stem and the aequalis reversed ii baseplate were retained from previous surgery.

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported that patient (b)(6) underwent a revision surgery seven years after primary study surgery due to instability/dislocation."there was also loosening of the prosthesis, rotator cuff insufficiency, poly wear, and the patient had pain." "aequalis reversed ii glenosphere was removed, as well as aequalis ascend flex reversed insert and tray.Insert was replaced to 42+9a; the tray was replaced to a high+0." the aequalis ascend flex stem and the aequalis reversed ii baseplate were retained from previous surgery.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13049290
• MDR Text Key: 285480299
• Report Number: 3000931034-2021-00355
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386941078
• UDI-Public: 03700386941078
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DWF520
• Device Catalogue Number: DWF520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 58 KG