MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 20 STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD120
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	02/19/2019
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
Tornier shoulder outcomes study - shout (b)(6).Loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture date of explant: (b)(6) 2019.Resolved without sequelae: (b)(6) 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.
Event or Problem Description
Tornier shoulder outcomes study - shout (subject 108-00045) loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture date of explant: (b)(6) 2019.Resolved without sequelae: 21 may 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.
Additional Manufacturer Narrative
The reported event could be confirmed.Devices were not returned for investigation, but evidences were provided, based on x-rays and surgery reports which match the alleged failure.The provided pre-op x-rays show radiolucency around the peripheral screws (glenoid loosening), breakage of a peripheral screw and a baseplate bone graft out of the glenoid bone (glenoid fracture).Since surgery reports and images were provided, the opinion of a medical expert was sought and stated as following: "this patient was revised in 2015 (revision with conversion from anatomic to reversed and iliac crest bone graft of the glenoid).The x-rays show a failure of the iliac crest graft (radiolucency) and part of the graft being displaced with the glenoid baseplate" (glenoid fracture)."no doubt that a screw broke (one of the 32 mm screws)"."most likely partial resorption of the graft (radiolucency) leading to partial loosening of the baseplate, followed by a traumatic fracture of the graft displacing the baseplate together with a part of the bone graft".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.In this case, the patient conditions may have contributed to this event.It is very unlikely that the devices could have caused the reported event.More detailed information about the complaint event (as patient conditions, post-operative images before the fall) as well as the affected devices must be available in order to determine clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 20 STERILE
• 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: 18419282
• Report Number: 3000931034-2023-00487
• Device Sequence Number: 6760818
• Product Code: PHX
• UDI-Device Identifier: 03700386917080
• UDI-Public: 03700386917080
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 04/27/2020
• Device Catalogue Number: DWD120
• Device Lot Number: 5566AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2015
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 53 KG