MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS FLEX REVIVE DISTAL STEM 11DIA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ARS741802
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that patient had pain ("worsening pain") in the right shoulder.Post-operative complication 5 months after previous surgery.Action taken: medication ; injection- 1ml kenalog, 2ml lidocaine, 7ml ropivicaine.Patient is also seeing a neurologist and will follow up with us after 3 months.
Additional Manufacturer Narrative
Please note that corrections were made to the following sections: d4 - expiration date; h4 - manufacturing date; h6 - device code; h6 - method code.The reported event could be confirmed, although the device was not returned but few x-rays & medication details were shared which confirms the alleged failure.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.A few x-rays were provided which were presented to our health care professional for evaluation, question about most likely reason for the reported event i.E the pain the patient is experiencing, to which medical expert opined: ¿patient 80+ years with status after proximal humeral fracture that was addressed with orif (plates and screws) with clear signs of non-union, secondary displacement of the proximal humeral fragment and plate with screw pull out.The postoperative x-rays after the conversion of the attempted osteosynthesis to a flex revive reversed tsa, show clear signs of proximal radiolucency around the proximal half of the revive stem and signs of subsidence as well.It proves that the stem is loose and that most likely explains the complaints of the patient.¿.[¿].Do you see any factor that could have contributed to the reported event when it comes to surgical technique, which maybe you could see on the x-rays post op? i believe the surgeon has done a good job on implantation of the revive-implant as such, especially if you consider the fracture sequalae pre-operatively.In retrospect, a longer implant might have prevented the proximal bone loss from becoming symptomatic.[¿].Based on the available information and the opinion received from the medical expert, the most probable cause of the issue is stem loosening combined with the selection of a stem that is a too short.The root cause was therefore attributed to a combination of user & patient related issues.If any further information is provided, the complaint report will be updated.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that patient had pain ("worsening pain") in the right shoulder.Post-operative complication 5 months after previous surgery.Action taken: medication ; injection- 1ml kenalog, 2ml lidocaine, 7ml ropivicaine.Patient is also seeing a neurologist and will follow up with us after 3 months.

• Brand Name: AEQUALIS FLEX REVIVE DISTAL STEM 11DIA
• 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: 13472504
• Report Number: 3004983210-2022-00012
• Device Sequence Number: 14670164
• Product Code: KWS
• UDI-Device Identifier: 00846832069606
• UDI-Public: 00846832069606
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 03/09/2025
• Device Model Number: ARS741802
• Device Catalogue Number: ARS741802
• Device Lot Number: AZ2519290075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 72 KG