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	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Patient had the locking cap and assembly screw from the stem implant back out post-operatively.
Additional Manufacturer Narrative
Correction: h6 (device) code.Based on the provided x-rays, the post-operative migration of both the assembly screw and locking cap could be confirmed.The device inspection revealed the following: visual inspection: the returned device shows slight thread wear on the assembly screw and locking cap can be explained by implant backing out.Aside from minor surface scratches and mild discoloration on the proximal body and bone fragments on the distal stem, no significant damage is evident.Moreover, a functional inspection was performed to verify the fitment of the assembly screw and locking cap with proximal body and distal stem, confirming that they fit as intended.However, it is not possible to evaluate the adequacy of the torque applied during the procedure.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.Based on investigation, the root cause was attributed to a user related issue.Most likely, the event was caused by improper fitment of the components during surgery.If more information is provided, the case will be reassessed.
Event or Problem Description
Patient had the locking cap and assembly screw from the stem implant back out post-operatively.

• 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: 22556099
• Report Number: 0001649390-2025-00530
• Device Sequence Number: 18551115
• Product Code: KWS
• UDI-Device Identifier: 00846832093250
• UDI-Public: (01)00846832093250(11)231109(17)281109
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: AZ1823202015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female