MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 38MM REVERSE LINER +0 S; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	LNR-0990-200-380S
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a shoulder surgery had been performed on (b)(6) 2023, patient experienced dislocation.During procedure, it was observed that the reverse liner was able to rock slightly in the stem and that it was severely deformed from the dislocation.This adverse event was addressed by revision surgery on (b)(6) 2024, to exchange the 38mm reverse liner +0 s.Patient's current health is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, this case reports that three months following implantation of the reverse liner a revision surgery was performed due to reportedly being ¿severely deformed from the dislocation.¿ the patient is a 51-year-old male.Per case details, the reverse liner was able to rock slightly in the stem and was exchanged during the revision.Three intraoperative photos were provided for review and confirm the deformation which appears to be the tract of the dislocated head.Based on the limited information provided the clinical root cause of the reported events could not be determined.We cannot rule out trauma or extreme motion or laxity within the joint.The patient impact beyond the reported revision could not be determined.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 instructions for use documents for aetos shoulder system revealed in post operative section that postoperative patient care and directions and warnings to patients by physicians are extremely important.Normal daily activity may be resumed at the physician¿s direction.Also it is state in warning section that excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints tend to adversely affect shoulder replacement implants.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, patient condition, and/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
H3,h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, three intraoperative photos were provided for review and confirm the deformation which appears to be the tract of the dislocated head.Based on the limited information provided the clinical root cause of the reported events could not be determined.Although we cannot rule out improper implant selection, trauma, non-compliance with post-operative treatment plans, activity level, or a component malperformance as likely contributory factors.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 instructions for use documents for aetos shoulder system revealed in post operative section that postoperative patient care and directions and warnings to patients by physicians are extremely important.Normal daily activity may be resumed at the physician¿s direction.Also it is state in warning section that excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints tend to adversely affect shoulder replacement implants.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.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.

• Brand Name: 38MM REVERSE LINER +0 S
• 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: 18977082
• Report Number: 3002788818-2024-00042
• Device Sequence Number: 6213383
• Product Code: PHX
• UDI-Device Identifier: 00885556810170
• UDI-Public: 885556810170
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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
• Device Expiration Date: 01/01/2026
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 06/06/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/10/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male