MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN 36 +6MM ASCEND FLEX HUMERAL LINER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 03/01/2024

Event Type  Injury  

Event Description

As reported: "revision was of a stryker reverse shoulder for instability.The 36mm glenosphere, 36 +6mm ascend flex humeral liner and 3.5mm high offset ascend flex tray were replaced with larger sizes to ensure stability.The event occurred on (b)(6) 2024.It is unknown when the patient first started experiencing the instability.".

Manufacturer Narrative

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

Manufacturer Narrative

Please note correction to d9/h3.The reported event could not be confirmed, since the device was not returned for evaluation and the available pictures are not sufficient to confirm the alleged failure.The device inspection revealed the following: the visual inspection of the available pictures reveals no signs of damage and the provided photos didn't provide much information to confirm the event.The device history record could not be reviewed because the affected device was not returned, and the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.

Event Description

As reported: "revision was of a stryker reverse shoulder for instability.The 36mm glenosphere, 36 +6mm ascend flex humeral liner and 3.5mm high offset ascend flex tray were replaced with larger sizes to ensure stability.The event occurred on (b)(6) 2024.It is unknown when the patient first started experiencing the instability.".

• Brand Name: UNKNOWN 36 +6MM ASCEND FLEX HUMERAL LINER
• 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: 19005938
• MDR Text Key: 338939860
• Report Number: 3000931034-2024-00176
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/20/2024
• 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