MAUDE Adverse Event Report: TORNIER INC TORNIER HRS LOCKING CAP; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS655200
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that eight-month postoperative imaging revealed gapping at the surgical site.The initial account indicated that only modular components¿including the polyethylene insert, tray, locking cap, and assembly screw¿were exchanged under fluoroscopic guidance.However, this was later corrected to reflect that the entire humeral construct was removed and replaced with a 230 mm construct.
Additional Manufacturer Narrative
The reported event was confirmed.The device was not returned, but evidence based on x-rays and video was provided, which matches the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.Since data, x-rays and a video were provided, the opinion of the medical expert was sought and stated as follows: "the x-rays confirm some gapping (dissociation) between the proximal body and the stem.The bone stock proximally is limited, allowing for the implant to rotate now, the splines are worn down.The video confirms the axial rotation of the proximal body relative to the stem, due to the worn-down splines.Since there is no comparison with early postoperative x-rays and the device was not returned to the manufacturer, technical assessment is not possible.The event is confirmed but the root cause of this event cannot be determined from the information available".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.
Event or Problem Description
It was reported that eight-month postoperative imaging revealed gapping at the surgical site.The initial account indicated that only modular components¿including the polyethylene insert, tray, locking cap, and assembly screw¿were exchanged under fluoroscopic guidance.However, this was later corrected to reflect that the entire humeral construct was removed and replaced with a 230 mm construct.

• Brand Name: TORNIER HRS LOCKING CAP
• 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: 23301375
• Report Number: 0001649390-2025-00718
• Device Sequence Number: 14674984
• Product Code: KWS
• UDI-Device Identifier: 00846832093007
• UDI-Public: (01)00846832093007(11)240214(17)290214(21)AZ723128079
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: ARS655200
• Device Lot Number: AZ723128079
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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 Sex: Unknown