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

Catalog Number	ARS655200
Medical Device Problem Codes	Biocompatibility (2886); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Original procedure took place in 2024.Procedure was a revision of another companies anatomic shoulder replacement.Revision on a poly swap and glenosphere exchange.X-rays in theatre show flex revive screw and cap have backed out of prosthesis making the construct loose.Patient showed clear signs of metalosis and query infection.All implants extracted and cement spacer implanted.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.However, based on the provided x-rays a formal medical opinion was asked, the device was used as intended.The post-operative loosening observed pertains to the modular components of the stem rather than the loss of osseointegration.However, due to the lack of information on the initial procedure such as the cleanliness of the components and the torque applied during assembly an assessment of contributing factors remains inconclusive.The x-ray does indicate that the assembly screw has backed out, leading to a slight separation between the proximal and distal stem components.Establishing the root cause as a patient-related issue with certainty would require higher-quality imaging, surgical reports, and direct examination of the implant.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 any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Original procedure took place in 2024.Procedure was a revision of another companies anatomic shoulder replacement.Revision on a poly swap and glenosphere exchange.X-rays in theatre show flex revive screw and cap have backed out of prosthesis making the construct loose.Patient showed clear signs of metallosis and query infection.All implants extracted and cement spacer implanted.

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21880945
• Report Number: 0001649390-2025-00268
• Device Sequence Number: 8632173
• Product Code: KWS
• UDI-Device Identifier: 00846832093007
• UDI-Public: (01)00846832093007(11)210302(17)260302(21)AZ3022154013
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Expiration Date: 03/02/2026
• Device Catalogue Number: ARS655200
• Device Lot Number: AZ3022154013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• 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: 79 YR
• Patient Sex: Unknown