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	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient had revision surgery of revive stem with pyrocarbon head.It was a conversion to reverse after recurrent dislocations.Items were intact and removed safely.No further information was provided.
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, the patient had revision surgery of revive stem with pyrocarbon head.It was a conversion to reverse after recurrent dislocations.Items were intact and removed safely.No further information was provided.
Additional Manufacturer Narrative
The reported event could be confirmed, since medical data were provided.A device inspection was not possible since the affected device was not returned for investigation.Since data were provided, the opinion of the medical expert was requested and stated as following- first, i would like to mention that the off-label use of the pychh is twofold in this case.The pychh is intended to be used with the tornier flex stem only use with revive is off-label use.Also, the indication is off-label use- revision of a non-union of a proximal humeral fracture.Radiographically the adverse event of superior dislocation of the shoulder joint is confirmed, indicating significant soft tissue insufficiency.There are several factors in play-revision surgery, soft tissue insufficiency, proximal humeral bone loss.This is not an implant related issue.Based on investigation, the root cause is multi-factorial including patient factors such as soft tissue insufficiency and proximal humeral bone loss.It is also important to note the user element to this event.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.

• 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: 24521622
• Report Number: 3000931034-2026-00247
• Device Sequence Number: 21258720
• Product Code: QKW
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: DEN220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: DWH139
• Device Lot Number: 1343BA
• Was Device Available for Evaluation?: No
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 48 YR
• Patient Sex: Female