MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. GLENOID BASEPLATE 10 DEG FW AUG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	GBP-0990-502-10F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Post Operative Wound Infection (2446)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right total shoulder arthroplasty surgery had been performed on (b)(6) 2024, the patient experienced post operative wound infection/excessive postoperative wound drainage.This adverse event was treated by irrigation and debridement of the joint on (b)(6) 2024, in which.Patient is currently recovering.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that per complaint details, the 74-year-old male study patient underwent irrigation and debridement of the joint approximately 5 weeks post right reverse shoulder arthroplasty due to post-operative wound infection/excessive postoperative wound drainage.The provided report forms document the serious device adverse event as severe, unanticipated procedural complication, definitely related to the study procedure but unrelated to the study device with date of onset (b)(6) 2024.Documentation within the report forms shows the adverse event was treated with irrigation and debridement in the operation room and antibiotic therapy 6 weeks for the culture results of streptococcus dysgalactiae (suspected to be a superficial wound infection) which is ongoing with a recovering/resolving outcome as of (b)(6) 2024 documentation.Reportedly, the adverse event was likely due to a post-operative superficial wound infection (which is a known surgical complication) with causative organism resulted as streptococcus dysgalactiae.Patient impact per the report forms include the excessive drainage, wound infection, irrigation and debridement procedure of the post-surgical wound along with the prescribed 6-weeks (dual) antibiotic therapy.For the glenoid baseplate, glenosphere concentric, meta humeral stem, reverse liner, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the center screw and the locking screws, the devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the glenoid baseplate, a review of complaint history revealed a similar event 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.For the glenosphere concentric, meta humeral stem, reverse liner, a review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.For the center screw and the locking screws, a review of complaint history for the previous 12 months 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.For the glenoid baseplate, glenosphere concentric, meta humeral stem, reverse liner, a review of the sterilization records revealed the batches were sterilized within normal parameters.For the center screw and the locking screws, a sterilization records review could not be performed as the batch numbers were not available.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, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should 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: GLENOID BASEPLATE 10 DEG FW AUG
• 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: 19857575
• Report Number: 3002788818-2024-00089
• Device Sequence Number: 8159666
• Product Code: PHX
• UDI-Device Identifier: 00885556814383
• UDI-Public: 885556814383
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: GBP-0990-502-10F
• Device Lot Number: 700010984
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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: GLS0990-506-3803C/38MM GLENOSPHERE CONCENTRIC +3MM; LNR-0990-202-380L/38MM REVERSE LINER +0 L; MEDICATION FOR INFECTION: DOXYCYCLINE HYCLATE, AUG; SCW-0990-504-15/4.5MM LOCKING SCREW 15MM; SCW-0990-504-30/4.5MM LOCKING SCREW 30MM; SCW-0990-507-30/4.5MM CENTER SCREW 30MM; STEM-0990-100-004/META HUMERAL STEM SIZE 4 L
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG