MAUDE Adverse Event Report: LIMACORPORATE SPA METAL-BACK (TI6AL4V + POROTI) METAL-BACK SMALL-R; SMR METAL BACK GLENOID

Model Number 1375.21.005

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (#201713981) did not show any anomaly on the 69 smr metal back glenoid manufactured with this lot #.No other complaints received on the same lot#.We will send a final mdr once the evaluation will be completed.

Event Description

During surgery, after prosthesis reduction, it was found that the metal back glenoid already implanted failed to be fixed as a consequence of the patient's glenoid cavity of scapula fractured (root cause of bone fracture is unknown, but patient suffers of pre-existing rheumatoid arthritis).Then, a humeral head replacement was immediately needed causing a prolonged surgery time of 30 minutes.Surgeon satisfied with the final stability of the implant.Event happened in (b)(6) on (b)(6) 2018.

• Brand Name: METAL-BACK (TI6AL4V + POROTI) METAL-BACK SMALL-R
• Type of Device: SMR METAL BACK GLENOID
• Manufacturer (Section D): LIMACORPORATE SPA
• MDR Report Key: 7608837
• MDR Text Key: 111311298
• Report Number: 3008021110-2018-00043
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 1375.21.005
• Device Lot Number: 201713981
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2018
• 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