MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX1.5MM ECC; SHOULDER JOINT HUMERAL CERAMIC HEAD

Catalog Number	DWH048
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Muscle/Tendon Damage (4532)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Pt fell over and tore subscapularis.Surgeon wasn¿t sure if he needed to replace the head.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned.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.In the indications for use, in anatomic configuration, the ifu mentioned, the tornier flex shoulder system is to be used only in patients with an intact or reconstructable rotator cuff.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The event was caused by an explantation of the humeral head whereas the ifu mention that the tornier flex shoulder system can be used in patients with a reconstructable rotator cuff.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, the pt fell over and tore subscapularis.Surgeon wasn't sure if he needed to replace the head.No further information was provided.
Additional Manufacturer Narrative
Device code updated.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned.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.In the indications for use, in anatomic configuration, the ifu mentioned ,the tornier flex shoulder system is to be used only in patients with an intact or reconstructable rotator cuff.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause of the rotator cuff tear that caused the revision is due the patient¿s fall, and therefore is patient related.As for the re-use of the same brand of device after the rotator cuff tear was reported, the root cause is due to an off label use of the surgeon.Indeed, the ifu mentions that the tornier flex shoulder system can only be used in patients with a reconstructable rotator cuff.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, the pt fell over and tore subscapularis.Surgeon wasn¿t sure if he needed to replace the head.No further information was provided.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 48MMX18MMX1.5MM ECC
• Common Device Name: SHOULDER JOINT HUMERAL CERAMIC HEAD
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22530892
• Report Number: 3000931034-2025-00390
• Device Sequence Number: 12766762
• Product Code: QKW
• UDI-Device Identifier: 03700434019544
• UDI-Public: (01)03700434019544(11)240522(17)290522
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: DEN220012
• 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,Followup
• Report Date (Section B): 11/24/2025

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: DWH048
• Device Lot Number: 8202BA
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/30/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/08/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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 Age: 37 YR
• Patient Sex: Male