MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWF520

Device Problems Unstable (1667); Migration (4003)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device remains implanted in the patient.

Event Description

It was reported that a patient was in a motor vehicle accident and developed severe shoulder pain.X-rays showed possible humeral component loosening.Ct scan demonstrate superomedial cortical loosening along the humeral component.The revision surgery has been completed.The issue was resolved with sequelae.

Manufacturer Narrative

The reported event could not be confirmed since the involved device were not returned for evaluation and no other evidences were provided.Only elements were provided based on the reported data in the clinical study.Since some data were provided, the opinion of a medical expert was sought and stated as following: "the reported accident may have caused soft tissue damage/ and or muscle weakness, leading to subsequent instability"."the final partial revision was an exchange of the humeral tray and inlay to address an instability of the shoulder.The stem was left in place.The surgery did not address cortical loosening"."this definitively is off-label use (.) that could lead to early failure of the prosthesis".In this case, the patient conditions may have contributed to this event ("patient was in a motor vehicle accident and developed severe shoulder pain¿).But, it was also reported in the clinical study that competitive glenoid components were implanted with the humeral compatible tornier components.As a reminder, the instructions for use clearly state that the association of the tornier flex shoulder system humeral components with other glenoid components than those recommended in the ifu, must not be used ("combinations of components: the tornier flex shoulder system in reversed configuration must be used in association with the aequalis reversed, aequalis reversed ii glenoid implant or tornier perform reversed augmented glenoid system").Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an off-label use (components incompatibility).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 devices are returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that a patient was in a motor vehicle accident and developed severe shoulder pain.X-rays showed possible humeral component loosening.Ct scan demonstrate superomedial cortical loosening along the humeral component.The revision surgery has been completed.The issue was resolved with sequelae.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM 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: 15474205
• MDR Text Key: 300553607
• Report Number: 3000931034-2022-00327
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434019100
• UDI-Public: 03700434019100
• 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,Followup
• Report Date: 12/15/2022

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?: 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?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/15/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 75 KG