MAUDE Adverse Event Report: TORNIER INC TORNIER SIMPLICITI HUM HEAD SIZE 5 2X23; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Model Number 7122876

Device Problem Difficult to Remove (1528)

Patient Problem Joint Laxity (4526)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation.Photos were provided from the complaint reporter; however, the device was covered in biological material and a device inspection was not possible.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.

• Brand Name: TORNIER SIMPLICITI HUM HEAD SIZE 5 2X23
• 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: 16743225
• MDR Text Key: 313327335
• Report Number: 0001649390-2023-00055
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00846832090495
• UDI-Public: 00846832090495
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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 Model Number: 7122876
• Device Catalogue Number: 7122876
• Device Lot Number: 3211AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 95 KG