MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. RSS GLENOSPHERE. CONCENTRIC-S. 5MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	GLS-0961-05C-S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right rtsa surgery had been performed on (b)(6) 2023, the patient attended clinic on (b)(6) 2023 where the surgeon determined that the glenosphere had dissociated from the baseplate.This adverse event was treated by a revision surgery on (b)(6) 2023, in which the glenosphere and liner implants were removed.The surgeon also removed any bone surrounding the baseplate.Current health status of patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, as of the date of this medical investigation, the requested clinical documentation had not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Per case details, the patient underwent a revision approximately six (6) weeks after a right reverse total shoulder arthroplasty was performed due to ¿the glenosphere had dissociated from the baseplate¿.Reportedly, the glenosphere, liner and ¿any bone surrounding the baseplate¿ were removed.Additional information regarding the replacement of the components and the patient current health status was not provided.The patient impact beyond the reported glenosphere disassociation from the baseplate and subsequent revision cannot be determined.Therefore, no further clinical/medical assessment can be rendered.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 of the glenosphere revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history of the liner 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 titan total shoulder system revealed that migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.This has been identified as an adverse event.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.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 traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.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: RSS GLENOSPHERE. CONCENTRIC-S. 5MM
• 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: 17515272
• Report Number: 3002788818-2023-00059
• Device Sequence Number: 8306215
• Product Code: PHX
• UDI-Device Identifier: 00885556863817
• UDI-Public: 00885556863817
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K213827
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: GLS-0961-05C-S
• Device Lot Number: 213600E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: LNR-0960-191-3S / LOT: 210756GE
• Patient Age: 65 YR
• Patient Sex: Female