MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD Ø42 MM

Model Number 1322.09.420

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing charts of the involved lot# (1700343), no pre-existing anomaly was found.This is the first and only complaint received on this lot#.We will proceed with further investigations and submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery of a total anatomic shoulder replacement to reverse due to cuff failure.Revision surgery was performed on (b)(6) 2019 and the primary surgery was performed on (b)(6) 2018.The humeral head involved has code 1322.09.420, lot# 1700343.According to the information provided, the reason for cuff failure was unknown.However, the surgeon remarked may have done humeral cut slightly too high.Event occurred in (b)(6).

Manufacturer Narrative

By the initial description reported, event was classified as "only cuff failure related" and the smr humeral head code 1322.09.420 was indicated as suspected code.Complaint investigation showed that the metal back code 1375.20.005 (not marked in usa) was more correctly identifiable as the suspected one.Foreword made, please find below the investigation performed: check of the dhr: by the check of the manufacturing charts of the involved lot#1806628 (product not marked in usa), no pre-existing anomaly was found.This is the first and only complaint received on this lot#.Explant analysis: no explants available for further analysis (discarded as per hospital policy) a picture of the explants was received: no signs of implant damages visible.X-rays analysis: we received the pre-op revision x-rays (no exact date provided) sending them to our medical consultant for a clinical opinion.Following the medical judgment received: "i agree the body too long, head too high, but also i think the glenoid base plate is a little too low as well.All these things will contribute to cuff failure.So, in summary surgical factor is the main reason for failure." by the analysis performed, surgical factor seems to be the main reason for the prosthesis failure.Event not product related.Pms data: we are aware of a total of 4 conversion from smr anatomic total to smr reverse due to cuff failure caused by poor primary implant positioning on a total of 39197 smr anatomic total implants performed ww.Specific revision rate: (b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

Event Description

Smr anatomic total revision surgery due to cuff failure performed on (b)(6) 2019.Primary surgery was performed on (b)(6) 2018.During the revision, smr anatomic prosthesis was converted to smr reverse.According to the info provided, surgeon responsible for both the previous and the revision surgery commented that improper initial prosthesis positioning (he may have done humeral cut slightly too high during the primary surgery) could have contributed to the event.Surgeon was happy with the final stability of the prosthesis.Event occurred in australia.

• Brand Name: SMR HUMERAL HEAD Ø42 MM
• Type of Device: SMR HUMERAL HEAD Ø42 MM
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 8310618
• MDR Text Key: 135183653
• Report Number: 3008021110-2019-00013
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.420
• Device Lot Number: 1711202
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention