MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 42MM REVERSE LINER +3 L; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	LNR-0990-202-423L
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).H3,h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a rsa surgery had been performed on (b)(6) 2025, the patient experienced the disassociation of the 42mm reverse liner +3 l from the humeral spacer +9 large.This adverse event was solved by a revision surgery on (b)(6) 2025, in which the poly, spacer and stem were removed.Another companies distal stem and tray were used to support the aetos baseplate and glenosphere.Current health status of patient is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the liner is heavily scratched and scuffed, the spacer is discolored and worn from use.The spacer has damage to the edges.All items are worn from use.The complaint description alleges product dislocated.Plastic is easily distorted when attempting to implant, especially when the mating surface that is rigid and harder than the plastic (e.G.Titanium, cocr, etc.).Surface finish damage (e.G.Dings, scratches, scuffs, rubs, etc.) and critical feature distortion (e.G.Warping, twisting, rupturing, etc.) are sufficient to alter the measurements during evaluation.For this reason, no dimensional analysis will be conducted.If additional complaints for this batch are submitted, this file will be reviewed for trending purposes.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 based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use 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 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.Factors that could contribute to the reported event include injury, patient condition, postoperative care, size selected or abnormal loading of limb.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 REVERSE LINER +3 L
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24052137
• Report Number: 3002788818-2026-00005
• Device Sequence Number: 9707006
• Product Code: PHX
• UDI-Device Identifier: 00885556810804
• UDI-Public: 885556810804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: LNR-0990-202-423L
• Device Lot Number: 700012057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLS0990-506-4203C / LOT NUMBER: 700012057.; LNR-0990-202-423L / LOT NUMBER: 700012057.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male