MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36MM X 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWD180

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

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

Event Date 11/06/2023

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.H3 other text : device is retained by surgeon.

Event Description

As reported: "primary reverse shoulder replacement (right side) performed in (b)(6) 2022.Patient had complained of significant pain for many recent months, with inability to move her prosthetic shoulder (joint).Revision surgery was performed where all implants were removed and a competitor rsa prosthesis was implanted.Surgeon commented that the glenoid baseplate, augmented with approximately 10mm of bone graft during the primary surgery, had over-lateralised the gleno-humeral joint line, leading to the pain / reduced range of motion.".

Event Description

As reported: "primary reverse shoulder replacement (right side) performed in (b)(6) 2022.Patient had complained of significant pain for many recent months, with inability to move her prosthetic shoulder (joint).Revision surgery was performed where all implants were removed and a competitor rsa prosthesis was implanted.Surgeon commented that the glenoid baseplate, augmented with approximately 10mm of bone graft during the primary surgery, had over-lateralised the gleno-humeral joint line, leading to the pain / reduced range of motion.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 36MM X 25MM
• 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: 18252021
• MDR Text Key: 329549710
• Report Number: 3000931034-2023-00445
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWD180
• Device Lot Number: AD9800001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 80 KG