MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 46MMX17MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	03/01/2024
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: "adverse event: patient experiencing pain.Diagnosed with rotator cuff failure post arthroplasty.Required intervention to prevent life-threatening illness or injury, or permanent impairment or damage.: yes original surgery ¿ (anatomic configuration) date of implant: on (b)6) 2014 stem ¿ aequalis ascend flex 4a standard ptc humeral stem humeral head- ascend flex standard low offset 46 x17 aequalis (humeral index 6.5) glenoid ¿ perform- pegged m35 revision implants ¿ (revision to reversed configuration) date of revision surgery: on (b)(6) 2024 stem- retained explantation of the following device components: humeral head- ascend flex standard low offset 46 x17 aequalis (humeral index 6.5) glenoid ¿ perform- pegged m35 implantation of the following device components: tray- high offset tray +0mm¿ insert- standard 36 dia.(+) 6mm/7.5c glenoid- baseplate- perform reversed glenoid- lateralized baseplate (+3mm), 25mm glenoid- glenosphere- standard 36mm diameter".
Event or Problem Description
As reported: "adverse event: : patient experiencing pain.Diagnosed with rotator cuff failure post arthroplasty.Required intervention to prevent life-threatening illness or injury, or permanent impairment or damage.: yes.Original surgery ¿ (anatomic configuration) date of implant: (b)(6) 2014.¿ stem ¿ aequalis ascend flex 4a standard ptc humeral stem.¿ humeral head- ascend flex standard low offset 46 x17 aequalis (humeral index 6.5).¿ glenoid ¿ perform- pegged m35.Revision implants ¿ (revision to reversed configuration) date of revision surgery: (b)(6) 2024.¿ stem- retained.Explantation of the following device components: ¿ humeral head- ascend flex standard low offset 46 x17 aequalis (humeral index 6.5).¿ glenoid ¿ perform- pegged m35.Implantation of the following device components: ¿ tray- high offset tray +0mm.¿ insert- standard 36 dia.(+) 6mm/7.5c.¿ glenoid- baseplate- perform reversed glenoid- lateralized baseplate (+3mm), 25mm.¿ glenoid- glenosphere- standard 36mm diameter".
Additional Manufacturer Narrative
Please note correction to lot number.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.However, it should be noted that the device was implanted on (b)(6) 2014 and explanted on (b)(6) 2024.It has nearly been 10 years device has been in the patient.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD LOW OFFSET 46MMX17MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 19607495
• Report Number: 3000931034-2024-00351
• Device Sequence Number: 15042690
• Product Code: KWS
• UDI-Device Identifier: 03700434022520
• UDI-Public: 03700434022520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 06/26/2019
• Device Catalogue Number: DWF046
• Device Lot Number: 4727AO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 59 KG