MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWB993
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/02/2021
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 on a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient was involved in a motor vehicle accident and experienced new onset of shoulder pain after that.The x-rays showed a subsidence of humeral component.The patient had the insert and glenosphere revised.
Event or Problem Description
It was reported that the patient was involved in a motor vehicle accident and experienced new onset of shoulder pain after that.The x-rays showed a subsidence of humeral component.The patient had the insert and glenosphere revised.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since data were provided, the opinion of a medical expert was sought and stated as following: ''there are several scenarios (.) the cause of the patient¿s pain is more complex than one would expect on first sight": "firstly, (.) severe notching, involving the scapula, the inferior screw(s) and the central post.This must have led to wear of the polyethylene insert, which in turn may have caused the beginning of bone resorption around the humeral and glenoid component.Secondly, it is possible to have a traumatic subsidence of the humeral component.(.) pain cannot be seen, and in this case the undermining of the glenoid component may have played a role as well.In this case the trauma may have affected the glenoid component as well, acute-o chronic loosening of the glenoid component.Thirdly, there is the factor of the possible presence of a low-virulent micro-organism, that (beside the chronic scapular notching) may explain that the patient has never been pain-free after the index surgery.All in all a complex case, that only can be solved with extra information (consecutive x-rays, bacteriological information, and early post-trauma x-rays before the revision took place)".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.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 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): 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: 14684938
• Report Number: 0001649390-2022-00022
• Device Sequence Number: 11940176
• Product Code: KWS
• UDI-Device Identifier: 03700386916540
• UDI-Public: 03700386916540
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 09/18/2017
• Device Model Number: DWB993
• Device Catalogue Number: DWB993
• Device Lot Number: 8956AL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 136 KG