MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. RSS GLENOID BASEPLATE-S; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	GBP-0961-094-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after surgery was performed on (b)(6) 2023, patient experienced a dislocation.This adverse event was treated by a revision surgery on (b)(6) 2023.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after surgery was performed on (b)(6) 2023, patient experienced a dislocation due to physical activity that occurred in the few days following the surgery.This adverse event was treated by a revision surgery on (b)(6) 2023.Patient is doing well and recovering.
Additional Manufacturer Narrative
The product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified no similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision surgery cannot be determined.No further clinical assessment can be rendered at this time.Visual inspection: visual inspection was unable to be performed because the device was not returned for evaluation.The complaint alleges that revision surgery was required.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the device has not been returned for evaluation, a definitive root cause could not be determined.The reverse shoulder system (rss) consists of several implanted components: the humeral body, the baseplate and screws, the humeral liner, humeral stem, and glenosphere.The glenoid baseplate is a metal implant which is implanted in the glenoid and secured by screws.The complaint alleges that the glenoid baseplate was dislocated several days post-implantation.Risk documentation for the rss product line indicates that potential causes for the reported event include incorrect surgical technique, incorrect patient selection, and inappropriate activity/handling post-implantation.The complaint description indicates that the dislocation was caused by ¿physical activity that occurred in the few days following the surgery¿, supporting inappropriate activity as the most likely cause.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: RSS GLENOID BASEPLATE-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: 16448654
• Report Number: 3002788818-2023-00019
• Device Sequence Number: 17610554
• Product Code: PHX
• UDI-Device Identifier: 00885556860281
• UDI-Public: 00885556860281
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K181999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2026
• Device Model Number: GBP-0961-094-S
• Device Catalogue Number: GBP-0961-094-S
• Device Lot Number: 213599E
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 04/20/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/11/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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: BBS-0960-21STD/REVERSE BODY STANDARD AND BODY SCRE; GLS-0961-05E-S/RSS GLENOSPHERE. ECCENTRIC-S. 5MM; LNR-0960-191-0S/RSS HXL LINER STANDARD. +0S; SCW-0961-046-15/RSS 4.5MM STAR SCREW AND CAP 15MM; SCW-0961-046-15/RSS 4.5MM STAR SCREW AND CAP 15MM; SCW-0961-046-25/RSS 4.5MM STAR SCREW AND CAP 25MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female