MAUDE Adverse Event Report: SERF CI / E NOVAE DUAL MOBILITY LINER

Model Number	CI 45/22.2 E
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serf ci/e liner is not involved in the system failure but it had to be replaced due to the femoral head retentivity system.Not returned.
Event or Problem Description
The surgery occurred on (b)(6) 2016 and was due to a patient fall and subsequently loosening their implants.

• Brand Name: CI / E NOVAE DUAL MOBILITY LINER
• Common Device Name: DUAL MOBILITY LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyeres; decines cedex, 69153 ; FR 69153
• MDR Report Key: 5882021
• Report Number: 3008668801-2016-00007
• Device Sequence Number: 692805
• Product Code: LZO
• UDI-Device Identifier: 03662200005819
• UDI-Public: 03662200005819
• 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: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/17/2016

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: 01/09/2017
• Device Model Number: CI 45/22.2 E
• Device Catalogue Number: RM54202245
• Device Lot Number: 1207224A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/17/2016
• 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: Required Intervention
• Patient Age: 53 YR