MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 42MM GLENOSPHERE CONCENTRIC; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	GLS0990-506-4200C
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tsa surgery, upon routine implantation of the 42mm glenosphere concentric, the set screw inside of it would not fully engage with the glenoid baseplate.Upon finally removing the implant, it was discovered that the set screw itself had broken off from the device and had to be extracted separately from the baseplate.Furthermore, while trying to extract the faulty glenosphere, the t-20 driver 4.5mm peripheral screws were starting to show signs of stripping in the driver tip threads.It is unknown how the procedure was resumed or if there was any delay.No further consequences were reported at the moment.
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The device was returned in two pieces, the set screw and a portion of the retainer was evenly broken off of the glenosphere.The tabbed portion of the retainer was still held within the glenosphere.There was no observed damage to the screw threads.The hexalobe feature on the screw did show signs of stripping.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed 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.According with the implant and instrumentation manufacturing specification , all implants and instrumentation will be 100% visually inspected.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, and/or excessive forces.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: 42MM GLENOSPHERE CONCENTRIC
• Common Device Name: 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: 20517068
• Report Number: 3002788818-2024-00109
• Device Sequence Number: 8768028
• Product Code: PHX
• UDI-Device Identifier: 00885556814451
• UDI-Public: 885556814451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: GLS0990-506-4200C
• Device Lot Number: 700008977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown