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

Catalog Number	GLS0990-506-4203C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a shoulder replacement surgery had been performed on (b)(6) 2022, the patient developed an infection.This adverse event was treated with i&d and a revision surgery on (b)(6) 2024, in which one (1) 42mm glenosphere concentric +3mm and one (1) 42mm reverse liner +3 l were replaced.Patient's current health status in unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the revision was reportedly due to an infection.Based on the provided radiological imaging and intra-op photos, the source of the reported infection cannot be concluded, and definitive contributing clinical factors cannot be confirmed.Post-operative infections are a known occurrence and is not indicative of a component malperformance.Hematogenous spread also cannot be ruled out.The current patient status is unknown.The patient impact includes a periprosthetic joint infection treated with irrigation and debridement and subsequent revision within four months of implantation.Further impact cannot be determined, although a post-surgical convalescence would be anticipated.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 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 devices.A review of the instructions for use documents for aetos¿ shoulder system revealed that infection may be included as an adverse effect.A review of the risk management files 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 evidence to conclude 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.
Additional Manufacturer Narrative
Additional information: d10 (concomitant device added).

• Brand Name: 42MM GLENOSPHERE CONCENTRIC +3MM
• 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: 18792557
• Report Number: 3002788818-2024-00028
• Device Sequence Number: 8296605
• Product Code: PHX
• UDI-Device Identifier: 00885556871652
• UDI-Public: 885556871652
• 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
• 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): 08/20/2024

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 Catalogue Number: GLS0990-506-4203C
• Device Lot Number: 700003254
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 08/20/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/02/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: LNR-0990-202-423L / LOT: 700001208
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male