MAUDE Adverse Event Report: TORNIER S.A.S. AEQREVSD FX/ADAPTER LATRLZD HMRL INSRT DIA36MM LATERALIZ+6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWD860
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	10/09/2024
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
Patient underwent reverse shoulder replacement.Post-op period was uneventful until patient's prosthetic shoulder joint dislocated.Joint was closed reduced that evening, under anaesthesia.Joint dislocated again the following day.Decision made by surgeon to perform an open surgical procedure, to determine the cause of the instability.During this procedure, the greater tuberosity, which was repaired during the primary procedure, was found to be re-fractured, and had pulled away from the proximal humerus, with mild bone resorption.Surgeon was unable to repair / reduce it.Joint found to be unstable, with current poly insert.This poly insert removed, and discarded, and after multiple trilling with both standard and retentive poly inserts, a definitive retentive insert was implanted - joint found to be stable through a satisfactory range of motion, with no impingement.
Event or Problem Description
Patient underwent reverse shoulder replacement.Post-op period was uneventful until patient's prosthetic shoulder joint dislocated.Joint was closed reduced that evening, under anaesthesia.Joint dislocated again the following day.Decision made by surgeon to perform an open surgical procedure, to determine the cause of the instability.During this procedure, the greater tuberosity, which was repaired during the primary procedure, was found to be re-fractured, and had pulled away from the proximal humerus, with mild bone resorption.Surgeon was unable to repair / reduce it.Joint found to be unstable, with current poly insert.This poly insert removed, and discarded, and after multiple trialling with both standard and retentive poly inserts, a definitive retentive insert was implanted - joint found to be stable through a satisfactory range of motion, with no impingement.
Additional Manufacturer Narrative
Correction - please refer h6 - health impact code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQREVSD FX/ADAPTER LATRLZD HMRL INSRT DIA36MM LATERALIZ+6MM
• 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: 20629055
• Report Number: 3000931034-2024-00643
• Device Sequence Number: 20815382
• Product Code: PHX
• UDI-Device Identifier: 03700386931499
• UDI-Public: (01)03700386931499(11)240602(17)290602(21)7976BA010
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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 Catalogue Number: DWD860
• Device Lot Number: 7976BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 85 KG