MAUDE Adverse Event Report: FH INDUSTRIE ESOP; ESOP FEMORAL SIZER

Catalog Number	210874
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the insertion of a hip prosthesis, the tip of the esop femoral sizer broke in the femur.

• Brand Name: ESOP
• Common Device Name: ESOP FEMORAL SIZER
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 7984875
• Report Number: 3003898228-2018-00016
• Device Sequence Number: 11111241
• Product Code: LXH
• UDI-Device Identifier: 03661489108747
• UDI-Public: 03661489108747
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: D114497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 210874
• Device Lot Number: N690448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 10/19/2018
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 98