MAUDE Adverse Event Report: TORNIER INC PERFORM CENTERED HUMERAL HEAD COUPLER TI; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	DWT100
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Laxity (4526); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
A revision surgery was performed due to patient dissatisfaction with the outcome of the original surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since medical imaging of the alleged event were provided and confirmed the need for a revision.The device inspection revealed the following: an evaluation of the provided medical imaging by a stryker hcp reveals upward migration of the humerus and is out of alignment with the curvature of the negative glenoid space.This combined with the implant being well fixed and well positioned within the humerus itself is evidence of a rotator cuff deficiency leading to the scheduled revision.A functional and dimensional inspection was not possible since the devices were not returned.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to a patient factors issue related issue.The event was caused by rotator cuff deficiency.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A revision surgery was performed due to patient dissatisfaction with the outcome of the original surgery.

• Brand Name: PERFORM CENTERED HUMERAL HEAD COUPLER TI
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 23514003
• Report Number: 0001649390-2025-00803
• Device Sequence Number: 9667257
• Product Code: HSD
• UDI-Device Identifier: 00846832085088
• UDI-Public: (01)00846832085088(11)240529(17)290529(21)AH3237026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: DWT100
• Device Lot Number: AH3237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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