MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 34MM REVERSE LINER PLS 6 SML; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	LNR-0990-200-346S
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sections b3 and g3 were updated.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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.
Event or Problem Description
It was reported that after a total shoulder arthroplasty surgery performed on (b)(6) 2024, there were suspicions that one (1) 34mm reverse liner +6 s was warped due to the patient dislocating repeatedly.This adverse event was resolved by a revision surgery on (b)(6) 2024, in which it was found that there was some warping around what would be the inferior lip of the liner, and it was dissociated.The surgeon exchanged the poly.No defects were found with the glenosphere.It is unknown the patient's current health status.
Additional Manufacturer Narrative
Additional information: a2, a3.Corrected data: b5, h6 (health effect - clinical code).
Event or Problem Description
It was reported that after a total shoulder arthroplasty surgery performed on (b)(6) 2024, the patient sustained a fall, following dislocation and attempted closed reduction.There were suspicions that one (1) 34mm reverse liner +6 s was warped due to the patient dislocating repeatedly.This adverse event was resolved by a revision surgery on (b)(6) 2024, in which it was found that there was some warping around what would be the inferior lip of the liner, and it was dissociated.The surgeon exchanged the poly.No defects were found with the glenosphere; it was just swapped out for safety.It is unknown the patient's current health status.

• Brand Name: 34MM REVERSE LINER PLS 6 SML
• 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: 21748757
• Report Number: 3002788818-2025-00031
• Device Sequence Number: 9537458
• Product Code: KWS
• UDI-Device Identifier: 00885556810972
• UDI-Public: 885556810972
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: LNR-0990-200-346S
• Device Lot Number: 700007230
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/03/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female