MAUDE Adverse Event Report: SERF NOVAE STICK; DUAL MOBILITY ACETABULAR CUP

Model Number RM50400053

Device Problems Failure To Adhere Or Bond (1031); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 01/18/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The surgeon has cemented a novae stick size 53 in an acetabular shell, preliminarily separated from its liner, after he determined a high instability during the surgery.This assembly and technique are not validated by serf and are not therefore indicated in the surgical technique or in the implant's indications.In the light of these observations, we consider that our product is not incriminated in the therapeutic failure.The structure has been extracted and replaced with a gap cage (non serf product) and a new novae stick size 49.

Event Description

After he determined a high instability during the operation, the surgeon has cemented novae stick size 53 in an implanted acetabular shell which was preliminarily separated from its liner.She dislocated that construct (out the front), because there was not enough abduction (closure).The surgeon explanted that entire construct and re-implanted a tm gap cage with this new (size 49) stick fit cup.

• Brand Name: NOVAE STICK
• Type of Device: DUAL MOBILITY ACETABULAR CUP
• Manufacturer (Section D): SERF; 85 avenue des bruyeres; decines cedex, 69153 ; FR 69153
• Manufacturer (Section G): SERF; 85 avenue des bruyères; decines cedex, 69153 ; FR 69153
• Manufacturer Contact: jean-luc aurelle ; 85 avenue des bruyères; decines cedex, 69153 ; FR 69153 ; 3347205601
• MDR Report Key: 5443963
• MDR Text Key: 38441637
• Report Number: 3008668801-2016-00001
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03662200005734
• UDI-Public: 03662200005734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: RM50400053
• Device Lot Number: 1302083A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR