MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD, DIA. 42 MM

Model Number 1322.09.420

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/08/2014

Event Type  Injury  

Event Description

This is a revision surgery from smr anatomic total to smr reverse after shoulder anterior dislocation.The original surgery was performed on (b)(6) 2014, the conversion to smr reverse has been performed on (b)(6) 2014.The event occurred in (b)(6).

Manufacturer Narrative

According to the event description, the component which dislocated is the humeral head.The check of it s work cycle did not show any dimensional anomaly; a total of 60 humeral heads have been manufactured with the lot # 201311363, and we did not received any other signaling on this lot #.We know that the explants are not available for investigation; we have requested to the complaint source further information on the event (e.G., x-rays, confirmation that the prosthetic components were well fixed on each other at the time of revision), but we received confirmation that no further info is available; therefore we could not perform a deeper investigation, and understand how much the implantation technique or patient condition could have contributed to the early dislocation.Based on our analysis with the poor info provided, we believe that the device could perform well, and that the reason for the shoulder dislocation is not related to the humeral head itself.This is the (b)(4) case of reported shoulder instability/dislocation with a smr anatomic total prosthesis.By the events information and out analysis, only 2 of these cases can be mainly attributed to the product; for all the others a patient trauma, condition or pathology (e.G.Rotator cuff failure), sometimes combined with an improper surgical technique by the surgeon during the original surgery, significantly contributed to the incident.By our post-market surveillance data, a total of about (b)(4) smr anatomic total prostheses were implanted worldwide since 2002.Therefore the total revision rate due to smr anatomic total instability/dislocation is 0.17% while the revision rate "product related" due to smr anatomic total instability dislocation is 0.02%.

• Brand Name: SMR HUMERAL HEAD, DIA. 42 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; villanova di san daniele 0000 ; IT 0000
• Manufacturer Contact: via nazionale 52; villanova di san daniele 0000 ; 432945511
• MDR Report Key: 4017936
• MDR Text Key: 20265992
• Report Number: 3008021110-2014-00014
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: 1322.09.420
• Device Lot Number: 201311363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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