MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER, L1 POLY LINER, SMALL-R

Model Number 1377.50.005

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

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

Event Date 02/04/2014

Event Type  malfunction  

Event Description

During a surgery dated on (b)(6) 2014, after insertion of the l1 metal back glenoid, the l1 liner was deemed to have "too much movement" after locking mechanism completed.The surgeon removed the small-r metal back and liner to implant a new metal back with new liner (size small).Upon new prosthesis implantation the surgeon was happy with the fixation.The event occurred in (b)(6).

Manufacturer Narrative

We checked the work cycle of the poly liner and metal back involved (size small-r) without finding any dimensional anomaly.Also, we did not receive any other signaling related to these lot of devices.A total of 51 l1 liners have been manufactured with the lot # 201214487, and 36 of them have been implanted.We took another liner and metal back belonging to the same lot of those involved in this intra-operative issue.After a dimensional check (which confirmed the absence of dimensional anomalies), we performed a functional test by coupling the two devices as per surgical technique.The liner was inserted into the metal back by pushing it with the fingers; an audible "click" was heard during the insertion, confirming the functionality of the mechanism.The liner was then stable inside the metal back, without any movement.According to the above test, we believe that there is no malfunction of the device.We did not receive the liner and metal back involved at the moment, but we know they are being returned to us.We will submit a follow-up report after analysis on them.

• Brand Name: SMR SHOULDER, L1 POLY LINER, SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele del friuli ; IT
• Manufacturer Contact: via nazionale 52; villanova di san daniele del friuli 33038 ; 432945511
• MDR Report Key: 3845333
• MDR Text Key: 4686029
• Report Number: 3008021110-2014-00003
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113254
• 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: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 1377.50.005
• Device Lot Number: 201214487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: METAL BACK GLENOID SMALL-R
• Patient Outcome(s): Hospitalization