MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 38MM REVERSE LINER +6 S; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number LNR-0990-200-386S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was reported that, after an aetos implant surgery was performed on (b)(6) 2023, the patient experienced a poly dissociation.This adverse event was treated by a revision surgery on (b)(6) 2024, in which the 38mm reverse liner +6 s and the 38mm glenosphere concentric were exchanged.Both implants were upsized to 42mm implants.Patient's current health status is unknown.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a reverse shoulder replacement with aetos was performed on (b)(6) 2023, the patient experienced a poly dissociation.This adverse event was treated by a revision surgery on (b)(6) 2024, in which the 38mm reverse liner +6 s and the 38mm glenosphere concentric were exchanged.Both implants were upsized to 42mm implants.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, according to the report, the dissociation was not caused by injury, consequently, the surgeon was unsure of the exact cause of the dissociation.However, the surgeon did theorize the dissociation occurred in relation to the choice of the size of glenosphere.Therefore, the adverse event was likely procedure related and the devices had no influence on the event.Devices batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the liner for the previous 12 months did not reveal similar events for the listed device.A review of complaint history of the glenosphere for the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for aetos¿ shoulder system revealed that modular components must be assembled securely to prevent disassociation.Avoid repeated assembly and disassembly of the modular components which could compromise a critical locking action of the components.Additionally, periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components.This has been identified as an intraoperative and postoperative precaution.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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique or size selected.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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.G3, date received by manufacturer: corrected.

• Brand Name: 38MM REVERSE LINER +6 S
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18888386
• MDR Text Key: 337472848
• Report Number: 3002788818-2024-00034
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00885556810156
• UDI-Public: 885556810156
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LNR-0990-200-386S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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
• Treatment: 38MM GLENOSPHERE CONCENTRIC, GLS0990-506-3800C
• Patient Outcome(s): Required Intervention; Other