MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI NUCLEUS SIZE 3; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Catalog Number 7122867

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

The reported event that one patient required revision surgery due to unexplained pain could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available by the uk 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 uk registry are not published reports and therefore web link is not available.H3 other text : device disposition unknown.

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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6) 2012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) 2019 a patient required revision surgery due unexplained pain, which was not previously reported to the manufacturer.Revision procedure type : single stage revision.

• Brand Name: TORNIER SIMPLICITI NUCLEUS SIZE 3
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17909337
• MDR Text Key: 325338314
• Report Number: 0001649390-2023-00261
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143552
• 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: 10/10/2023

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: 7122867
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 96 KG