MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PROXIMAL BODY DIA 9; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS741701
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The disengagement of assembly screw within proximal and distal body causing the proximal part of revive stem to become unstable resulting in revision surgery was reported.Also, porous coating of proximal part of stem has eroded/come off the stems surface.Patient had symptoms and heard an audible clunk, x ray of stem confirmed issue.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed because the returned device does not provide evidence of any post-operative loosening issues.To verify this postoperative x rays would be required.The visual inspection of the returned device reveals that the cemented part of the proximal body is eroded and fell off from the device.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 the current information the definitive root cause of the observed coating detachment cannot be determined.While the images exhibit characteristics that may suggest removal related to mechanical stress this cannot be confirmed at this point.Additional details are necessary to establish whether the coating loss occurred in vivo during the revision procedure or as a consequence of extraction forces.If any further information is provided the investigation report will be reassessed.
Event or Problem Description
The disengagement of assembly screw within proximal and distal body causing the proximal part of revive stem to become unstable resulting in revision surgery was reported.Also, porous coating of proximal part of stem has eroded/come off the stems surface.Patient had symptoms and heard an audible clunk, x ray of stem confirmed issue.Later, it was reported that: the pre op revision x ray taken on (b)(6) 2025 showing plasma spray proximal coating has eroded as well as the proximal body disassociating from distal body.The remarkable circumstances related to the event was mentioned as infection potentially but has not been confirmed yet.No further information was provided.

• Brand Name: TORNIER HRS PROXIMAL BODY DIA 9
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23110905
• Report Number: 0001649390-2025-00669
• Device Sequence Number: 15920477
• Product Code: KWS
• UDI-Device Identifier: 00846832092703
• UDI-Public: (01)00846832092703(11)210930(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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 Expiration Date: 09/30/2026
• Device Catalogue Number: ARS741701
• Device Lot Number: AZ0621172
• 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: 08/23/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: 57 YR
• Patient Sex: Female