MAUDE Adverse Event Report: LIMACORPORATE SPA HUMERAL HEADS (COCRMO) DIA.42MM

Model Number 1322.09.420

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

No pre-existing defects were found by checking the manufacturing charts of the lot# 201605356, on a total of 72 smr humeral head dia.42mm manufactured with this lot#.No other complaints reported on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Shoulder revision surgery due to pain and loss of range of motion performed on (b)(6) 2018.According to the info reported, likely cause for revision surgery appears to be a subtle resorption of greater tubercle prominence combined with a user error in implanting the humeral head too high during the previous surgery performed on (b)(6) 2017.Surgeon happy with final stability of the implant.Event happened in (b)(6).

• Brand Name: HUMERAL HEADS (COCRMO) DIA.42MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.42MM
• Manufacturer (Section D): LIMACORPORATE SPA
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 7573455
• MDR Text Key: 110222267
• Report Number: 3008021110-2018-00045
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K100858
• 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

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1322.09.420
• Device Lot Number: 201605356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2016
• 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