MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 39MM 9TH B 12.5DG; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number DWF392B

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Subluxation (4525)

Event Date 06/24/2020

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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6)2012 ¿ (b)(6) 2022.During the review of the report, it was identified that on (b)(6) 2020 a patient required revision surgery due to dislocation/subluxation, which was not previously reported to the manufacturer.Revision procedure type: single stage revision.

Manufacturer Narrative

It cannot be determined which, and if any of these, devices may have caused or contributed to the reported dislocation/subluxation since the device was not returned for evaluation and no other additional information will be made available by the national joint registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the national joint registry are not published reports and therefore web link is not available.H3 other text : device disposition unknown.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 39MM 9TH B 12.5DG
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 18812565
• MDR Text Key: 336619638
• Report Number: 3000931034-2024-00064
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K190521
• 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: 02/29/2024

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 Expiration Date: 10/25/2023
• Device Catalogue Number: DWF392B
• Device Lot Number: 1832AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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: 83 YR
• Patient Sex: Female