MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 38MM REVERSE LINER +0 S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	LNR-0990-200-380S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a total shoulder arthroplasty surgery was performed on (b)(6) 2023, the patient experienced poly dissociation for the third time.This adverse event was addressed by a revision surgery on (b)(6) 2024, during which all humeral components were removed and replaced with tornier flex components (competitor's devices).Upon inspection of the devices, it was noticed that a 38mm reverse liner +0 s had several wraps and defects along the outer edges.The patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
D4, d10, h4.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, no relevant supporting clinical information had been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time to determine the clinical root cause of the reported events.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.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 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 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 traumatic injury, size selected or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the device 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.
Additional Manufacturer Narrative
Additional information: a2, a3.Corrected data: b3, b5.
Event or Problem Description
It was reported that, after a second revision of total shoulder arthroplasty surgery performed on (b)(6) 2024, the patient experienced poly dissociation for the third time.This adverse event was addressed by a revision surgery on (b)(6) 2024, during which all humeral components were removed and replaced with tornier flex components (competitor's devices).Upon inspection of the devices, it was noticed that a 38mm reverse liner +0 s had several wraps and defects along the outer edges.The patient's current health status is unknown.

• Brand Name: 38MM REVERSE LINER +0 S
• Common Device Name: PROSTHESIS, SHOULDER, NON-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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19012319
• Report Number: 3002788818-2024-00048
• Device Sequence Number: 19803509
• Product Code: KWT
• UDI-Device Identifier: 00885556810170
• UDI-Public: 885556810170
• 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: 2023
• 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,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Catalogue Number: LNR-0990-200-380S
• Device Lot Number: 700003703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 05/03/2024; 04/29/2025
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/05/2024; 05/08/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: GLS0990-506-3800C / LOT: 700006390; PN: SPC-0990-204-S / LOT: 700006254; PN: STEM-0990-100-002 / LOT: 700007047
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male