MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD191
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery due to instability/dislocation.Stryker - tornier sas aequalis reversed ii glenoid sphere and zimmer reverse cup were removed.All other components retained.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Correction h6 method.The reported event could not be confirmed since the involved device was not returned for evaluation and no additional information will be provided.It was reported in the event description that competing humeral components were implanted with the tornier aequalis reversed glenoid components.As a reminder, the instructions for use clearly state that the association of the aequalis reversed glenoid components with other components than those recommended in the ifu, must not be used ("aequalis¿ reversed and aequalis¿ reversed ii glenoid implants are prostheses components of the aequalis¿ reversed and aequalis¿ reversed fracture shoulder prostheses.They must be used in association with: humeral implants aequalis¿ reversed, aequalis¿ reversed fracture or aequalis ¿ adjustable modular reversed shoulder, - or humeral implants tornier flex shoulder system in reverse configuration tornier implants must be assembled using tornier components defined as being compatible with one another").Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an off-label use.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device remains implanted in patient.
Event or Problem Description
It was reported that patient underwent a revision surgery due to instability/dislocation.Stryker - tornier sas aequalis reversed ii glenoid sphere and zimmer reverse cup were removed.All other components retained.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 29MM
• 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: 13743330
• Report Number: 3000931034-2022-00146
• Device Sequence Number: 14695197
• Product Code: KWS
• UDI-Device Identifier: 03700386935893
• UDI-Public: 03700386935893
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 07/05/2026
• Device Model Number: DWD191
• Device Catalogue Number: DWD191
• Device Lot Number: 5169AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 87 KG