MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. META HUMERAL STEM SIZE 1 S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number STEM-0990-100-001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, during a tsa, the meta humeral stem size 1 s was too large for the patient.This caused a proximal humerus fracture that was repaired with suture.Surgery was performed after a non-significant delay, with the same device.Patient's current health status is unknown.

Manufacturer Narrative

H10: h3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided fluoroscopy shows an implant within the humerus as well as a notch on the lateral cortex of the humerus but do not identify a clear fracture on the provided image or a method to repair, based on the information provided the clinical root cause of the fracture is human error as the chosen implant was too large.The patient impact is the fracture and postoperative convalescence period.No further assessment is warranted at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for aetos shoulder system revealed in precautions that knowledge of surgical techniques, proper reduction, selection and placement of implants, are essential to successful outcomes.Each surgeon must evaluate the appropriateness of the procedure and instruments used during the procedure.Besides, intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: META HUMERAL STEM SIZE 1 S
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18515063
• MDR Text Key: 332895496
• Report Number: 3002788818-2024-00008
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: STEM-0990-100-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2024
• 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