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

Catalog Number UNK_WTM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2004

Event Type  Injury  

Manufacturer Narrative

This record is a consolidation of events summarized as part of registry review, when the device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance registry review.The alleged patient experienced sizing issue which required revision surgery mentioned in the registry could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.More detailed information about the patient(s) medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of national registry released by(b)(6) registry.The report provides information on the usage and outcomes of the ascend flex hemi stemmed shoulder system.This report includes analysis of the clinical data that was collected on 394 patients, the cases in this study range from april 2004 and june 2021.This report was generated on (b)(6) 2021.During the review of the registry, it was not possible to establish a specific device details, patient information, and no additional device information will be made available.It was reported that one patient experienced incorrect sizing which required revision.

• Brand Name: UNKNOWN ASCEND FLEX HUMERAL STEM
• 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: 13404898
• MDR Text Key: 289285415
• Report Number: 3000931034-2022-00022
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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?: Yes
• Date Manufacturer Received: 01/07/2022
• 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): Hospitalization; Required Intervention