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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "patient underwent shoulder hemi-arthroplasty on (b)(6) 2023, for fracture proximal right humerus.Patient has experienced pain and reduced range of motion over recent months.Surgeon suspects joint is infected, due to 1 x swab returning positive for bacteria c.Acnes.Surgeon has decided on a 2-stage revision arthroplasty.Humeral prosthesis removed, with significant difficulty (humeral stem well fixed).Multiple tissue specimens taken.Explanted prosthesis discarded.Cement antibiotic spacer implanted.".
Additional Manufacturer Narrative
The reported event could not be confirmed, based on the evaluation done by medical experts on provided x-ray image.The device inspection was not possible as the product was not returned for investigation and provided image is not sufficient.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, design & manufacturing related problems were found during the investigation.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications and was sterilized according to procedure.No deviation for a non-conformance could be found.A review of the labeling did not indicate any abnormalities.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿the image shows a well-fixed implant, confirmed by the surgeon¿s observation.The image confirms the indication of a proximal humeral fracture.The image shows no signs of infection.¿ hence, the reported issue is not confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.However, infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention, and the aftercare.If any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "patient underwent shoulder hemi-arthroplasty on (b)(6) 2023, for fracture proximal right humerus.Patient has experienced pain and reduced range of motion over recent months.Surgeon suspects joint is infected, due to 1 x swab returning positive for bacteria c.Acnes.Surgeon has decided on a 2-stage revision arthroplasty.Humeral prosthesis removed, with significant difficulty (humeral stem well fixed).Multiple tissue specimens taken.Explanted prosthesis discarded.Cement antibiotic spacer implanted.".

• 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: 19105750
• Report Number: 3000931034-2024-00206
• Device Sequence Number: 12614322
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWH043
• Device Lot Number: 2963AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 105 KG