MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 26 STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWD126

Device Problem Osseointegration Problem (3003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)

Event Date 02/19/2019

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.

Event Description

Tornier shoulder outcomes study - shout (b)(6).Loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture date of explant: (b)(6) 2019.Resolved without sequelae: (b)(6) 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.

Manufacturer Narrative

The reported event could be confirmed.Devices were not returned for investigation, but evidences were provided, based on x-rays and surgery reports which match the alleged failure.The provided pre-op x-rays show radiolucency around the peripheral screws (glenoid loosening), breakage of a peripheral screw and a baseplate bone graft out of the glenoid bone (glenoid fracture).Since surgery reports and images were provided, the opinion of a medical expert was sought and stated as following: "this patient was revised in 2015 (revision with conversion from anatomic to reversed and iliac crest bone graft of the glenoid).The x-rays show a failure of the iliac crest graft (radiolucency) and part of the graft being displaced with the glenoid baseplate" (glenoid fracture)."no doubt that a screw broke (one of the 32 mm screws)"."most likely partial resorption of the graft (radiolucency) leading to partial loosening of the baseplate, followed by a traumatic fracture of the graft displacing the baseplate together with a part of the bone graft".A review of the device history for the reported lot did not indicate any abnormalities.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.In this case, the patient conditions may have contributed to this event.It is very unlikely that the devices could have caused the reported event.More detailed information about the complaint event (as patient conditions, post-operative images before the fall) as well as the affected devices must be available in order to determine clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

Event Description

Tornier shoulder outcomes study - shout ((b)(6)).Loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture.Date of explant: (b)(6) 2019.Resolved without sequelae: (b)(6) 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.

• Brand Name: AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 26 STERILE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18419285
• MDR Text Key: 331613410
• Report Number: 3000931034-2023-00486
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03700386917097
• UDI-Public: 03700386917097
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: DWD126
• Device Lot Number: 7039AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 53 KG