MAUDE Adverse Event Report: TORNIER INC CANNULATED COCR STANDARD GLENOSPHERE 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ1017301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed due to an acromial stress fracture.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
A revision surgery was performed due to an acromial stress fracture.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was not returned for evaluation, however confirmation was based on medical opinion requested for provided x-ray image.The device inspection was not possible as the product was not returned for investigation.However, based on provided image of x-ray and blueprint case study below is noted by medical expert: "postoperative imaging confirmed osteosynthesis of the fracture, these fractures are not typically the result of surgical error but rather an inherent biomechanical challenge of rtsa.The revision surgery was successfully executed in accordance with the preoperative planning with blueprint.The procedure addressed an acromial stress fracture, particularly in elderly patients where bone resilience may be compromised due to increased deltoid muscle tension." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED COCR STANDARD GLENOSPHERE 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23578124
• Report Number: 0001649390-2025-00828
• Device Sequence Number: 21147122
• Product Code: PHX
• UDI-Device Identifier: 00846832085644
• UDI-Public: (01)00846832085644(11)250418(17)300418(21)AI5030004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2025

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: Lay User/Patient
• Device Catalogue Number: DWJ1017301
• Device Lot Number: AI5030004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female