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

Catalog Number DWH043

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "an ascend flex pyrocarbon head was reversed to a total anatomical construct.The pyrocarbon head was removed easily and with minimal wear.Revision procedure." updated: reported patient complaint was pain.Ascend flex standard head with perform glenoid has been reimplanted.It was a left side shoulder.

Manufacturer Narrative

Reported event could not be since the returned device is conforming to specifications.The visual inspection reveals no defect, no impact, no scratch on the pyrocarbon humeral head.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint 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 more information is provided, the case will be reassessed.

Event Description

As reported: "an ascend flex pyrocarbon head was reversed to a total anatomical construct.The pyrocarbon head was removed easily and with minimal wear.Revision procedure." updated: reported patient complaint was pain.Ascend flex standard head with perform glenoid has been reimplanted.It was a left side shoulder.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 43MMX16MMX1.5MM ECC
• Type of Device: SHOULDER JOINT HUMERAL CERAMIC HEAD/METALLIC STEM CEMENTED OR UNCEMENTED
• 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: 17988950
• MDR Text Key: 326315458
• Report Number: 3000931034-2023-00365
• Device Sequence Number: 1
• Product Code: QKW
• UDI-Device Identifier: 03700434019469
• UDI-Public: 03700434019469
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: DWH043
• Device Lot Number: 5583AQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female