MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI NUCLEUS SIZE 1; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number 7122865

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

Patient Problems Implant Pain (4561); Swelling/ Edema (4577)

Event Date 12/12/2022

Event Type  Injury  

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 under catalog number dwg401 510k # k143552.Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device has been discarded.

Event Description

It was reported that a patient had a total shoulder replacement.During surgery, surgeon noted that a tendonous tear of the junction of the supraspinatus and subscapularis tendons existed.Surgeon performed a repair using anchors.Post-op rehabilitation proceeded without incident.However, several months following primary surgery, patient complained of increasing pain, swelling and instability of shoulder joint.Surgeon performed a shoulder arthroscopy, to discover full thickness tears of both of the afore mentioned tendons.Discussed with the patient, where a decision was made to convert the surgery to a reverse shoulder replacement.During surgery today, both humeral and glenoid components were removed, as per the recommended surgical technique.The surgeon has no explanation as to why the patient's rotator cuff tendons deteriorated in such a short period of time, rendering the prosthetic joint unstable, other than his belief that microscopic poly debris may have set up an inflammatory local response that inhibited the tendon tear to heal.All components discarded.

• Brand Name: TORNIER SIMPLICITI NUCLEUS SIZE 1
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• 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: 16118872
• MDR Text Key: 306880563
• Report Number: 0001649390-2023-00001
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2023

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: 7122865
• Device Lot Number: CC0918256096
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/08/2023
• 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: 75 YR
• Patient Sex: Female