MAUDE Adverse Event Report: TORNIER INC UNKNOWN_WRIGHT TORNIER-BLOOMINGTON_IMPLANT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	UNK_WTB
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, one of the surgeons recently had a case where the implant dissociated inside the patient shortly after the surgery.They planned the revision next week, but the surgeon would like us to send the dissociated implant off for testing to confirm it wasn't an issue with the implant itself.The surgeon requested more information.No further information was provided.
Event or Problem Description
It was reported that, one of the surgeons recently had a case where the implant dissociated inside the patient shortly after the surgery.They will be revising this next week but the surgeon would like us to send the dissociated implant off for testing to confirm it wasn't an issue with the implant itself.Would you be able to provide me with information about this process and what needs to be done from our end and also what will be investigated, as the surgeon is requesting more information.Additional information: the primary surgery was done on (b)(6) 2026.It was reported that, the patient presented with worsening pain over his right humerus which woke him up in the early hours of (b)(6) 2026.Even before that he had been requiring increasing degrees of painkillers i.E.Naproxen and co-codamol.He denied any trauma or unusual activity.The x-rays revealed that the junction between the metaphysis and the distal stem had become uncoupled and the screw was loose, leading to the mechanism not being in the original position as per the intraoperative images.It was reported that, lot of adhesions around the old scars, tuberosities well healed, very carefully exposed and interval developed old sutures removed, carefully, the tuberosities were tagged and exposed and well fixed distal stem, very difficult to remove, careful use of chisels and long drill bit and long k wires around the prosthesis under x-ray control, tip of drill bit broke, unable to retrieved (will be reported in another case), within canal distal to stem, decision to leave alone, removal of distally fixed stem using revision hip and shoulder extraction implants done without damaging humerus or causing fracture or osteotomising the shaft of humerus.
Additional Manufacturer Narrative
The reported event could be confirmed based on the medical expert opinion on the available radiographs.The device inspection revealed the following visual inspection confirmed that the returned item has no major visual defects.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 formal medical opinion was sought, which concluded the available operative notes, x-rays, and photographs of the explanted tornier hrs humeral implant suggest that the metaphyseal body and distal stem were assembled correctly during the primary procedure.However, it cannot be determined retrospectively whether the assembly screw was tightened to the recommended torque.Given that the distal stem remained well fixed, postoperative imaging was initially satisfactory, and the patient reported no trauma or unusual activity, the most likely mechanism of failure was progressive loosening of the assembly screw over time.This may have occurred due to micromotion of the metaphyseal component at the fracture site while the distal stem remained rigidly fixed within the humerus.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 labelling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the available evidence, a conclusive root cause cannot be established.Therefore, the most probable root cause of the stem-metaphysis dissociation is insufficient torque applied to the assembly screw during implantation, excessive motion between the metaphyseal and distal stem components caused by inadequate initial fracture-zone stability, or a combination of both factors.The evidence supports a gradual mechanical loosening process rather than an acute traumatic failure.If any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN_WRIGHT TORNIER-BLOOMINGTON_IMPLANT
• 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 ; +1(201)831-5000
• MDR Report Key: 25097893
• Report Number: 0001649390-2026-00400
• Device Sequence Number: 13259516
• Product Code: KWS
• UDI-Device Identifier: 00846832093250
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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