MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS655101
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a rsa revision case due to resorption/stability issues with their revive stem and perform reverse construct.The stem was swapped for a larger construct.There was no mechanical failures with them implant.The doctor blamed it on the patient condition.
Event or Problem Description
It was reported that the patient underwent a rsa revision case due to resorption/stability issues with their revive stem and perform reverse construct.The stem was swapped for a larger construct.There was no mechanical failures with them implant.The doctor blamed it on the patient condition.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.If more information is provided, the case will be reassessed.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 0MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23301370
• Report Number: 0001649390-2025-00712
• Device Sequence Number: 4889845
• Product Code: KWS
• UDI-Device Identifier: 00846832093250
• UDI-Public: (01)00846832093250(11)240717(17)290717(21)AZ2523276109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: ARS655101
• Device Lot Number: AZ2523276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: 71 YR
• Patient Sex: Unknown