MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II COMBO 36/42 INSERT TH.+6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWD988

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported that a patient required revision surgery due to wear on the glenoid inferior along with the patient having pain.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that a patient required revision surgery due to wear on the glenoid inferior along with the patient having pain.

Manufacturer Narrative

Please note correction to d9.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 II COMBO 36/42 INSERT TH.+6MM
• 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: 19037092
• MDR Text Key: 339297522
• Report Number: 3000931034-2024-00190
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03700386932731
• UDI-Public: 03700386932731
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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: DWD988
• Device Lot Number: 3662AX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 77 YR
• Patient Sex: Male