MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. META HUMERAL STEM SIZE 1 S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	STEM-0990-100-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right rsa surgery performed on (b)(6) 2024, the patient has been feeling pain in her shoulder.An external imaging center vendor made aware of tubercle fracture.It is unknown how is this issue being managed.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3,h6: 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 submitting this report in accordance with applicable regulations.If additional investigative findings or 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, after a right rsa surgery performed on (b)(6) 2024, the patient has been feeling pain in her shoulder.An external imaging center vendor made aware of tubercle fracture.The reported event resolved on (b)(6) 2024, with no treatment.
Additional Manufacturer Narrative
Additional information: b5, h6 (type of investigation), h10 (roi).H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the meta humeral stem size 1 s.Therefore, no investigation is deemed for the other devices.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the undated x-ray images confirm the tubercle fracture.Based on the information, the clinical root cause for the reported tubercle fracture was not known and it cannot be concluded that the reported event is related to a malperformance of the implant.There is no patient impact beyond the noted pain which as recovered with no intervention.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history 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 aetos shoulder system revealed that postoperative bone fracture may be included as an adverse effect.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 this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition, excessive forces and/or injury.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.H6 (health effect - clinical code and health effect - impact code).

• Brand Name: META HUMERAL STEM SIZE 1 S
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 21261039
• Report Number: 3002788818-2025-00009
• Device Sequence Number: 15796025
• Product Code: KWT
• UDI-Device Identifier: 00885556814215
• UDI-Public: 885556814215
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/18/2025

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: STEM-0990-100-001
• Device Lot Number: 700010889
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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: 34MM GLENOSPHERE CONCENTRIC +1MM, LOT#:700012318.; 34MM REVERSE LINER +0 S, LOT#:700011445.; BASEPLATE POST EXTENSION 10MM, LOT#:700009032.; GLENOID BASEPLATE 10 DEG FW AUG, LOT#:700016509.; OXYCODONE.; TRAMADOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 49 KG