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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3000931034-2023-00365
• Device Sequence Number: 8185151
• Product Code: QKW
• UDI-Device Identifier: 03700434019469
• UDI-Public: 03700434019469
• 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
• Report Date (Section B): 01/16/2024

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: 10/08/2020
• Device Catalogue Number: DWH043
• Device Lot Number: 5583AQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2015
• 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: Required Intervention
• Patient Sex: Female