MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED 4.5MM COMPRESSION SCREW 35 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	VDV235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a lawsuit that the patient reported having refractory pain and dysfunction of the shoulder which was refractory to conservative measures.Preoperative imaging was suggestive of loosening of the humeral component, specifically at the junction of the proximal humeral body to the humeral stem at the assembly screw junction.
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.The reported event could not be confirmed since the devices were not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned.Since elements were provided, the opinion of the medical expert was requested and stated as following: "i concur with the observation that the device list appears to list an excessive number of components for potential implantation in a single shoulder.It is possible that different stems were considered or utilized during the surgery.However, it is regrettable that there is an absence of a description regarding any purported event that may have resulted in a postoperative impact on the patient.Furthermore, there is a lack of additional clinical documentation, such as a surgical report, medical correspondence, or imaging of the shoulder.Regrettably, due to these limitations, i am unable to provide a medical assessment of this case".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.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.If the devices are returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not available.

• Brand Name: AEQUALIS REVERSED 4.5MM COMPRESSION SCREW 35 MM
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17906600
• Report Number: 3000931034-2023-00336
• Device Sequence Number: 7822885
• Product Code: KWS
• UDI-Device Identifier: 03700386917219
• UDI-Public: 03700386917219
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

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: VDV235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Female