MAUDE Adverse Event Report: TORNIER S.A.S. BASEPLATE REVERSED 2 LINE EXTENSTION 25X30; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWE730
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "instability/dislocation.Revision surgery (left shoulder).Humeral side components retained from first surgery".Series of events below: (b)(6) 2016: aequalis ascend flex humeral components / aequalis reversed ii glenoid components (with a threaded post baseplate) implanted (reversed configuration).(b)(6) 2018: patient fall from bed at home ("no fracture or prothesis dislocation") *.(b)(6) 2018: indication: medical evaluation of pain following trauma event.Diffuse bone demineralization.A dislocation backwards and downwards of the shoulder prosthesis.Absence of traumatic bone lesion clearly demonstrated (numerous arti-facts linked to the prosthesis.(b)(6) 2018: indication: medical evaluation after surgery.Dislocation of the total left reversed shoulder with a small fracture of the glenoid inferior screw.(b)(6) 2018: revision surgery with a reversed shoulder arthroplasty configuration.-explanted: glenoid components -retained: humeral components.-implanted: new baseplate (with long post baseplate) and sphere with graft.-sling, immobilization.
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: "instability/dislocation.Revision surgery (left shoulder).Humeral side components retained from first surgery".Series of events below: (b)(6)2016: aequalis ascend flex humeral components / aequalis reversed ii glenoid components (with a threaded post baseplate) implanted (reversed configuration).(b)(6)2018: patient fall from bed at home ("no fracture or prothesis dislocation") *.(b)(6)2018: indication: medical evaluation of pain following trauma event.Diffuse bone demineralization.A dislocation backwards and downwards of the shoulder prosthesis.Absence of traumatic bone lesion clearly demonstrated (numerous arti-facts linked to the prosthesis.(b)(6) 2018: indication: medical evaluation after surgery.Dislocation of the total left reversed shoulder with a small fracture of the glenoid inferior screw.(b)(6) 2018: revision surgery with a reversed shoulder arthroplasty configuration.-explanted: glenoid components.-retained: humeral components.-implanted: new baseplate (with long post baseplate) and sphere with graft.-sling, immobilization.
Additional Manufacturer Narrative
The reported even could be confirmed.The device was not returned for investigation but evidences were provided, based on provided images and medical reports which match the alleged failure.On the provided images taken before the revision surgery, we can observe that: -the glenoid sphere is completely disassembled from the insert.The shoulder joint is dislocated.-one of the peripheral screws is broken at the threading level in the bone.-a glenoid lucency/loosening is also noted.Since medical reports and images were provided, the opinion of a medical expert was sought and stated as following: ¿this case details the dislocation of a reverse shoulder prosthesis and the loosening of the aequalis reverse ii baseplate with bio-rsa.The first operative report describes an uneventful implantation of the rsa components.The second operative report, detailing the revision surgery, describes the loosening of the baseplate and the removal of the screws.It is important to note that after the removal of the loose baseplate and bone graft, the tip of the broken screw could be easily retrieved from the glenoid surface.It is highly probable that the screw tip of the inferior screw was removed, the screw holes were filled with bone graft material (a postoperative x-ray could confirm this with certainty).The baseplate loosening and the shoulder dislocation are most likely interconnected; the mobility of the glenosphere provided less stability to the rsa construct.The fall did not seem related the way it is described in the shout report ("site narrative: patient fall from bed on (b)(6) 2018 no fracture or dislocation of prothese").The most likely scenario is asymptomatic insufficient osseointegration and worsening of loosening by the fall, given the fracture of only one screw and the lack of gross fracturing of the glenoid.Medically it is usually described as ¿acute on chronic¿.Therefore, there are arguments for both perspectives: pre-existing lack of firm osseointegration, and a fall, eventually both leading to revision surgery.Root cause: patient-related factors leading to insufficient osseointegration of the bio-rsa construct at the glenoid side".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.Based on investigation, the root cause was attributed to a patient-related issue (patient condition).The failure was the most likely caused by an asymptomatic insufficient osseointegration at the glenoid side and worsening of loosening by the fall.If any additional information is provided, the investigation will be reassessed.

• Brand Name: BASEPLATE REVERSED 2 LINE EXTENSTION 25X30
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19467895
• Report Number: 3000931034-2024-00330
• Device Sequence Number: 7498095
• Product Code: PHX
• UDI-Device Identifier: 03700386952661
• UDI-Public: 03700386952661
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 08/24/2020
• Device Catalogue Number: DWE730
• Device Lot Number: 3513AQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2015
• 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: 68 YR
• Patient Sex: Female