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

Catalog Number GLS0990-506-4200C

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).B5: the patient's first revision surgery was reported to fda under manufacturer report number 3002788818-2023-00106 (internal reference (b)(4)).

Event Description

It was reported that, after a first revision surgery was performed on (b)(6) 2023 due to implant dislocation subsequent to a fall, the patient presented stiffness and woke up with a dislocated shoulder on (b)(6) 2023.It was noticed that the liner was adherent to the glenosphere, but dissociated from the stem.A second revision surgery was performed on (b)(6) 2024, during which he glenosphere was replaced with a 42mm glenosphere concentric +3mm, while the liner was replaced with a new one of the same part number.The humeral spacer +9 small, the 15 deg augment baseplate full wedge and the meta humeral stem size 2 s were retained.Patient's current health status is stable.

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 per complaint details, a 75 year old male patient who had experienced stiffness after the first reverse shoulder arthroplasty revision required a second revision approximately 6 weeks post first revision due to a shoulder dislocation during sleep.The surgeon provided a presentation which chronicled the first and second revision, both reportedly with ¿poly adherent to glenosphere, dissociated from stem¿.The surgeon noted, however, that ¿100% of reverse shoulder arthroplasty dislocations prior to this have been dissociation from glenosphere¿.The provided presentation with electronic photos of radiological imaging dated (b)(6) 2024 (approximately 6 weeks post second revision) appear to support the complaint showing dislocation of the glenosphere from the humeral side; however, unable to discern location of the poly liner in the images and cannot confirm ¿poly adherent to glenosphere¿ based on the images provided.The surgical technique does instruct to visually inspect the liner after impaction to ensure full seating as well as perform a pull test by hand to ensure full engagement and the instructions for use addresses secure modular component assembly as well.Reportedly, the glenosphere was replaced with a 42mm ¿lateralized¿, along with an identical liner exchange.The patient¿s current health status is reportedly ¿stable¿/¿doing well but scared as the second dislocation was not associated with trauma¿.It is unknown if the reported stiffness was an indication of an impingement or if there was possible ligament/tendon/muscle laxity following the first reverse shoulder revision post fall.As of the date of this medical investigation, the requested operative notes have not been provided.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.For the glenosphere concentric, humeral stem and the baseplate, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the reverse liner and the humeral spacer, batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the glenosphere concentric, a review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the humeral stem an the baseplate, a review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the humeral spacer, a review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.For reverse liner, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for aetos¿ shoulder system revealed that modular components must be assembled securely to prevent disassociation.Avoid repeated assembly and disassembly of the modular components which could compromise a critical locking action of the components.Additionally, periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components.This has been identified as an intraoperative and postoperative 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.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 traumatic injury, patient condition, postoperative care and/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.

Event Description

It was reported that, after a first revision surgery was performed on (b)(6) 2023 due to implant dislocation subsequent to a fall, the patient presented stiffness and woke up with a dislocated shoulder on (b)(6) 2023.It was noticed that the liner was adherent to the glenosphere, but dissociated from the stem.A second revision surgery was performed on (b)(6) 2023, during which the glenosphere was replaced with a 42mm glenosphere concentric +3mm, while the liner was replaced with a new one of the same part number.The humeral spacer +9 small, the 15 deg augment baseplate full wedge and the meta humeral stem size 2 s were retained.Patient's current health status is stable.

• Brand Name: 42MM GLENOSPHERE CONCENTRIC
• Type of Device: 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: 19199311
• MDR Text Key: 341238051
• Report Number: 3002788818-2024-00060
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GLS0990-506-4200C
• Device Lot Number: 700003357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 04/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 15D AUG BSPLT WDG (GBP-0990-502-15F,700006190).; 42MM RV LNR (LNR-0990-200-423S).; HRL SPCR+9 (SPC-0990-204-S).; MET HUM STM (STEM-0990-100-002,700006799).
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male