MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM; SHOULDER JOINT METAL PROSTHESIS

Model Number DIA. 9MM L100 MM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Bone Shedding Debris (4557)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Retained at medical facility.

Event Description

Surgeon removed old reversed 2 stem and poly due to notching of scapula.He also removed the glenosphere.Replacement glenosphere was our 10 degree tilt and the stem was replaced by another company model.Issue noted initially when reviewing x rays of patients shoulder.

Event Description

Surgeon removed old reversed 2 stem and poly due to notching of scapula.He also removed the glenosphere.Replacement glenosphere was our 10 degree tilt and the stem was replaced by a another company model.Issue noted initially when reviewing x rays of patients shoulder.

Manufacturer Narrative

Correction of h6 method code to "analysis of production record".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.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• 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: 11931299
• MDR Text Key: 254089364
• Report Number: 3000931034-2021-00262
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DIA. 9MM L100 MM
• Device Catalogue Number: DWB971
• Device Lot Number: 3561AL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female