MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PYROCARBON HUM HEAD DIA 43MMX16MMX1.5MM ECC; SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED

Model Number	DWH043
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to a screw from a prior surgery rubbing against pyrocarbon humeral head causing damage to the humeral head.The surgeon removed the humeral head and switched to a flex reverse construct because the glenoid was strongly anteverted and therefore he thought that an anatomical one would not have been stable.
Additional Manufacturer Narrative
Correction: d4 serial number.The reported event could be confirmed, since x-rays were provided.On the visual inspection of the device, we can observe that the layer of pyrocarbon is gone on a large third of the surface, but that the graphite below is little damaged.Since data and x-ray and medical report, the opinion of the medical expert was requested and stated as following: this is indeed an interesting case.The screw that was closest to the joint and was already sticking out of the bone at the articular side was left in place unfortunately.That is for sure a user-related issue.Also, the caution was ignored, by that taking a large risk.A surgeon related issue is the obvious root cause for this event.Based on investigation, the root cause was attributed to a user related issue.The event was caused because the product was used against the clear warning in the documentation.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to a screw from a prior surgery rubbing against pyrocarbon humeral head causing damage to the humeral head.The surgeon removed the humeral head and switched to a flex reverse construct because the glenoid was strongly anteverted and therefore he thought that an anatomical one would not have been stable.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 43MMX16MMX1.5MM ECC
• Common Device Name: SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16898427
• Report Number: 3000931034-2023-00129
• Device Sequence Number: 15165488
• Product Code: QKW
• UDI-Device Identifier: 03700434019469
• UDI-Public: 03700434019469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: DEN220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/24/2021
• Device Model Number: DWH043
• Device Catalogue Number: DWH043
• Device Lot Number: 7058AR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2016
• 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: 38 YR
• Patient Sex: Male