MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 26 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWD126

Device Problems Break (1069); Fracture (1260)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 01/17/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to loosening/lysis of the glenoid component.New tray/insert/glenosphere/baseplate were implanted, stem was retained from previous surgery.A broken screw was also noticed on the glenoid side and was completely removed.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Correction h6 clinical code.Two possible lot numbers for the screw are ac3969035 and ac2673015.In this case, since it has been reported that "the 2 multidirectional screws fitted initially are: (.) dwd126, lot ac3969035 (.) dwd126, batch ac2673015.It cannot be confirmed which one of these 2 screws was the one involved.Investigation conclusion: the reported event (post-operative glenoid loosening with screw breakage) could be confirmed.The devices were not returned but evidences were provided based on the reported data in the clinical study.Since data were provided, the opinion of a medical expert was sought and stated as following: "the surgical report doesn¿t mention anything out of the ordinary, except for the degeneration pattern of the glenoid.The surgeon addressed the deformity with a reversed tsa, using a bone graft around the central post of the glenoid baseplate.The ct-scan of (b)(6) 2019, that is approximately 6 months after the index surgery ((b)(6) 2019), the baseplate has migrated away from the glenoid, leaving behind the distal part of one broken baseplate screw.The bone graft was attached to the baseplate, thus the construct failed at the bone graft-glenoid interface.(.) the issue is primary a patient related factor (¿namely the bone graft did not heal properly/timely on the glenoid side, leading to baseplate migration and secondary screw breakage¿, ¿presence of poor bone quality¿), but on second thought, underestimation of the severity of the large subchondral cyst can be seen as a user-related issue (¿in retrospect the subchondral cyst was so large that primary fixation was already inadequate¿, ¿osteointegration was not sufficient¿)".Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an underestimation of the hcp of the patient's initial conditions.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.If more information is provided, the case will be reassessed.

Event Description

It was reported that the patient underwent a revision surgery due to loosening/lysis of the glenoid component.The patient reported having severe pain.New tray/ insert/ glenosphere/ baseplate were implanted, stem was retained from previous surgery.A broken screw was also noticed on the glenoid side and was completely removed.

• Brand Name: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 26 STERILE
• 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: 16358532
• MDR Text Key: 309365650
• Report Number: 3000931034-2023-00057
• Device Sequence Number: 1
• Product Code: KWS
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Catalogue Number: DWD126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/04/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 82 KG