MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWB993

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a revision of reverse ii glenoid and poly liner.The glenoid component had broken away from the glenoid.The glenosphere and baseplate had dissociated and there was poly wear.The implants were removed and replaced.A screw was used to remove the poly liner.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 MM
• 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: 18862247
• MDR Text Key: 337183198
• Report Number: 3000931034-2024-00098
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916540
• UDI-Public: 03700386916540
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWB993
• Device Lot Number: AE2222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• 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 Sex: Female