MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. GLENOID BASEPLATE ECCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	GBP-0990-501-2
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the aetos shoulder surgery performed on (b)(6) 2024, the patient experienced loosening of the glenoid baseplate eccentric in the left shoulder.The exact cause is unclear; however, it may be related to an early postoperative fall the patient had.This adverse event began on (b)(6) 2025 and it was diagnosed by a clinical study.This adverse event was treated by medication therapy and a revision reverse shoulder arthroplasty was considered to stabilize the baseplate, but the event remains unresolved.It is unknown if the revision surgery has been scheduled/performed.The patient¿s current health status is unknown.No additional complications have been reported.
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).This complaint was opened by smith+nephew to document a reported patient complication that includes reference to the use of a smith+nephew product without evidence of a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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.

• Brand Name: GLENOID BASEPLATE ECCENTRIC
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22640092
• Report Number: 3002788818-2025-00068
• Device Sequence Number: 13185531
• Product Code: KWS
• UDI-Device Identifier: 00885556808443
• UDI-Public: 885556808443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: GBP-0990-501-2
• Device Lot Number: 700007613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 34MM REV LNR +3S RENT:LNR0990-200-343SR,700001117; 34MMGLENOSPHCONC+1MM:GLS0990-506-3401C,700010217; META HUMRL STEM SZ 1S:STEM-0990-100-001,700006803
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG