MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI- CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWF510

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Inadequate Osseointegration (2646)

Event Date 04/29/2021

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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

Event Description

It was reported that there was a descaling and acute sepsis of the patient's right shoulder.

Manufacturer Narrative

The reported event could be confirmed, since the medical records confirm the infection and the loosening.The medical records were available and provided to the medical expertise for his opinion: "i believe the loosening is a result of the infection, and the mechanical stress applied to the joint during opening of the can most likely provoked the already loosening glenoid construction, causing the moment of acute pain.Infection will cause an inflammatory response of the whole joint, including the device-bone interfaces (the surgeon reports that also the humeral component was easily removed from the bone).The infection was caused by a typical skin bacterium, infecting the whole joint, including the graft.The origin of the infection is not due to the graft, the autograft itself is sterile when taken from the patient¿s own humerus." the root cause of this event is due to an infection caused by a typical skin bacterium.This infection then led to the loosening of the device.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that there was a descaling and acute sepsis of the patient's right shoulder.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 1.5MM OFFSET
• 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: 15278169
• MDR Text Key: 298431819
• Report Number: 3000931034-2022-00275
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWF510
• Device Catalogue Number: DWF510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• 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: 79 YR
• Patient Weight: 90 KG