MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWB971

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 10/07/2018

Event Type  Injury  

Event Description

The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6) 2022.During the review of the report, it was identified that on 07-october-2018 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but a similar device is commercially available cleared 510k k030941.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 was not necessary because the implant affected by this complaint has been manufactured prior to 2018.As a result, this implant is expired and can no longer be put on the market or implanted.The complaint history review found no other complaint recorded for this lot number.Moreover, the post market surveillance reviews have not identified any signals for similar issues that would have challenged the efficacy and safety of this product.A review of the labeling did not indicate any abnormalities.The nature of the complaint doesn¿t necessitate a drawing review.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.H3 other text : device not available.

• Brand Name: AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM
• 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: 18842438
• MDR Text Key: 336957056
• Report Number: 3000931034-2024-00085
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWB971
• Device Lot Number: 2422AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• 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: 52 YR
• Patient Sex: Female