MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II DIA25 L30 THREADED POST BASE PLATE; PROSTHESIS SHOULDER JOINT METAL

Model Number	DIA25 L30 THREADED POST BASE PLATE
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Case booked for a revision.Reversed threaded post baseplate put in, in (b)(6) 2019 needs to be revised, probably using a perform reverse, another reversed threaded post or convert to a hemi.Booking from surgeons rooms, after implant to patient (2019).
Additional Manufacturer Narrative
Corrections: please refer to g3 awareness date, h6 device code, component code, results code and conclusion code.H10 mfg narrative content.The reported event could be confirmed since evidences were provided.A device inspection was not necessary in this case.The x-rays show a loosened glenoid component of a reversed tsa with marked osteolysis of the glenoid bone.A broken screw is also observed on one of the two x-rays.On the other x-ray, we can note that the heads of the peripheral screws come out of the baseplate, as not well fixed to it.The products detail reveals that, the peripheral screws that were used to fix a glenoid threaded post baseplate to the glenoid bone, were not multidirectional locking screws but compression screws, whereas in the current aequalis reversed ii surgical techniques 4 multidirectional locking screws should be used ("all 4 holes of the threaded post baseplate are multidirectional locking screws").In this case, the use of compression screws (not intended for this type of baseplate) led in part to the glenoid components loosening with screw breakage.Furthermore, it cannot be excluded that there are some uncertainties about other causes such as, but not limited to, low grade infection, inappropriate soft tissue balancing creating high joint reaction forces, and or instability, which could have caused the loosening.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an inadequate peripheral screws choice.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Case booked for a revision.Reversed threaded post baseplate put in, in (b)(6) 2019 needs to be revised, probably using a perform reverse, another reversed threaded post or convert to a hemi.Booking from surgeons rooms, after implant to patient (2019) update (b)(6) 2021 : revision due to screw snapping and baseplate loosening.

• Brand Name: AEQUALIS REVERSED II DIA25 L30 THREADED POST BASE PLATE
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11933829
• Report Number: 3000931034-2021-00266
• Device Sequence Number: 4345216
• Product Code: KWS
• UDI-Device Identifier: 03700386952661
• UDI-Public: 03700386952661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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 Model Number: DIA25 L30 THREADED POST BASE PLATE
• Device Catalogue Number: DWE730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 12/29/2021
• 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 Sex: Female