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

Catalog Number	ARS655200
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that a revision surgery was performed due to a dissociated revive stem.The locking cap and screw were correctly assembled but became loose postoperatively, requiring surgical intervention.
Additional Manufacturer Narrative
Correction: g1 manufacturing site; h6 (device, results & clinical) codes.The reported event was confirmed, since a x-ray of the alleged event was provided and matches the event reported.The device inspection revealed the following: a medical expert evaluated the provided x-ray¿s and confirmed that the locking screw had backed out creating a gap between the proximal body and the stem spacer.Based on investigation, the root cause was attributed to an unknown factor, the case was evaluated by a medical professional and no root cause could be established based on the evidence provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 a revision surgery was performed due to a dissociated revive stem.The locking cap and screw were correctly assembled but became loose postoperatively, requiring surgical intervention.

• 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: 22687098
• Report Number: 0001649390-2025-00550
• Device Sequence Number: 9472822
• Product Code: KWS
• UDI-Device Identifier: 00846832093007
• UDI-Public: 00846832093007
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/09/2025

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: ARS655200
• Device Lot Number: UNKNOWN
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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