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

Model Number	RM50400053
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/18/2016
Additional 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 or Problem 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
• Common Device Name: DUAL MOBILITY ACETABULAR CUP
• Manufacturer (Section D): SERF; 85 avenue des bruyeres; decines cedex, 69153 ; FR 69153
• MDR Report Key: 5443963
• Report Number: 3008668801-2016-00001
• Device Sequence Number: 10824557
• Product Code: LZO
• UDI-Device Identifier: 03662200005734
• UDI-Public: 03662200005734
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: RM50400053
• Device Lot Number: 1302083A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2016
• Initial Report FDA Received Date: 02/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR