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	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that following a reverse arthroscopy of the right shoulder performed on (b)(6) 2019, the glenosphere component was found to be dislocated from the glenoid baseplate seen on x-rays evaluation at first postoperative visit on (b)(6) 2019 as the patient was asymptomatic.Therefore, revision surgery was performed on (b)(6) 2019 to correct this by explanting the glenosphere, the liner, and the peripheral screw 4 to replace them with new components.Outcome resolved without sequelae on patient.

• 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: 20447068
• Report Number: 3002788818-2024-00106
• Device Sequence Number: 18449593
• Product Code: PHX
• UDI-Device Identifier: 00885556863817
• UDI-Public: 885556863817
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K181999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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 Expiration Date: 04/30/2024
• Device Catalogue Number: GLS-0961-05C-S
• Device Lot Number: 192428
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 04/30/2019
• 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: BBS-0960-21SML / REVERSE BODY SMALL AND BODY SCREW; GBP-0961-094-S / RSS GLENOID BASEPLATE-S; LNR-0960-03S / LINER STANDARD 3; SCW-0961-046-15 / RSS 4.5MM STAR SCREW AND CAP 15M; SCW-0961-046-15 / RSS 4.5MM STAR SCREW AND CAP 15M; SCW-0961-046-20 / RSS 4.5MM STAR SCREW AND CAP 20M; SCW-0961-046-20 / RSS 4.5MM STAR SCREW AND CAP 20M; SCW-0961-046-25 / RSS 4.5MM STAR SCREW AND CAP 25M; STEM-0920-025-11 / TSS PRESS FIT STEM SZ. 11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG