MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 42MM GLENOSPHERE CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	GLS0990-506-4200C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left aetos reverse total shoulder arthroplasty done without complication on (b)(6) 2023, during the first post-operative visit, it was discovered that the patients left shoulder was infected.To treat this adverse event a revision surgery was performed on (b)(6) 2024 during which a 42mm glenosphere concentric and a 42mm reverse liner +6 l were explanted without issue, followed by a thorough irrigation with antibiotics of the infected left shoulder.The patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left aetos reverse total shoulder arthroplasty done without complication on (b)(6) 2023, during the first post-operative visit, it was discovered that the patients left shoulder was infected.To treat this adverse event a revision surgery was performed on (b)(6) 2023 during which a 42mm glenosphere concentric and a 42mm reverse liner +6 l were explanted without issue, followed by a thorough irrigation with antibiotics of the infected left shoulder.The patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided radiographic image appears to confirm the aetos components, however the radiographic image does not aid in determining the root cause of the reported unspecified infection and no other images were provided for comparison.No laboratory findings such as blood or tissue cultures were provided.The requested clinical documentation including the operative report has not been provided.The patient impact beyond the reported unspecified infection and the subsequent revision cannot be determined, and the patient¿s current health status remains unknown.Therefore, no further clinical/medical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for aetos¿ shoulder system non-sterile device reprocessing revealed that universal precautions are standards of infection control practices designed to reduce the risk of transmission of bloodborne infections.Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated devices.Exercise caution when handling devices with sharp points or cutting edges.This has been identified as a warning and 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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: 42MM GLENOSPHERE CONCENTRIC
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17691028
• Report Number: 3002788818-2023-00067
• Device Sequence Number: 14960529
• Product Code: KWS
• UDI-Device Identifier: 00885556814451
• UDI-Public: 885556814451
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2023
• 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): 10/20/2023

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: GLS0990-506-4200C
• Device Lot Number: 700002068
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/18/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/02/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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: 42MM REVERSE LINER +6 L; DURING REVISION: THOROUGH IRRIGATION WITH ANTIBIOT; GLENOID BASEPLATE 10 DEG FW AUG; META HUMERAL STEM SIZE 3 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown