MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM ECC; SHOULDER JOINT HUMERAL CERAMIC HEAD

Catalog Number	DWH139
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, pyrocarbon head chipped by surgeon during removal of osteophytes around the implant.Implant was fully intact prior to attempting removal.No further information was reported.
Event or Problem Description
It was reported that, pyrocarbon head chipped by surgeon during removal of osteophytes around the implant.Implant was fully intact prior to attempting removal.No further information was reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since a photo of the explanted device was provided.Photos of explanted devices are not sufficient to carry out product inspections related to the revision surgery.Visual inspection of the pyrocarbon humeral head confirmed the implant breakage intra-operative.Based on investigation, the root cause was attributed to a user related issue.The event was caused by an accidental shock with a metallic instrument (osteotome) during removal of osteophytes around 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.The ifu mention that pyrocarbon should not be damaged.Handling or contact of the implant with any metallic instrument is strictly not recommended.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM 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: 24005278
• Report Number: 3000931034-2026-00047
• Device Sequence Number: 9250284
• Product Code: QKW
• UDI-Device Identifier: 03700434019643
• UDI-Public: 03700434019643
• 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): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2020
• Device Catalogue Number: DWH139
• Device Lot Number: 8475AQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/19/2026; 04/17/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2015
• 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: Other
• Patient Sex: Male