MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM ECC; SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED

Catalog Number DWH139

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that the implant was found broken when the box was opened.The low offset version of the same diameter and height with no noted compromise to the fit.

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 Description

It was reported that the implant was found broken when the box was opened.The low offset version of the same diameter and height with no noted compromise to the fit.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation.Visual inspection: right half part: a defect (hole) is visible on bottom right, note red marks on top left are just blood left by surgeon¿s gloves.Left half part : defect corresponds exactly with the right part.Fracture is clearly passing in the middle of the defect.The pyrocarbon bearing surface component is fractured in 2 equal parts, fracture pass-ing by the center of the device.The only defect visible on the fracture plane is a cavity in the graphite material, on both halves, matching one with the other.This cavity is ovoid in shape (like a rugby ball) of about 700¿m in length and 500¿m in diameter.Surfaces of this cavity are not regular.This hole is situated in a position, near the inside surface of the morse taper.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: the chromium-cobalt double taper was verified with the 3-dimensional control equipment (ref # (b)(4)) and it was conformed to the specifications.Due to the nature of the returned pyrocarbon head, a dimensional inspection was not possible.Based on investigation, the root cause was attributed to a device material related issue.The event was caused by a cavity on the raw material.The event has been elevated to an nc.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.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM ECC
• Type of Device: 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: 17982331
• MDR Text Key: 326511576
• Report Number: 3000931034-2023-00364
• Device Sequence Number: 1
• Product Code: QKW
• UDI-Device Identifier: 03700434019643
• UDI-Public: 03700434019643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN220012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWH139
• Device Lot Number: 6526AZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1