MAUDE Adverse Event Report: SERF; PROSTHESIS, HIPEMI-CONSTRAINED

Catalog Number HRM-5420-28-49

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 08/04/2020

Event Type  Injury  

Event Description

A complaint was initiated for a patient who underwent a hip revision surgery on (b)(6) 2020.The original surgery is dated (b)(6) 2014.The reason for revision is reported patient fall.During the revision, the original insert was removed and replaced with a new component.

• Type of Device: PROSTHESIS, HIPEMI-CONSTRAINED
• Manufacturer (Section D): SERF; 85 avenue des bruy?res; d?cines-charpieu, 69150 ; FR 69150
• MDR Report Key: 10425141
• MDR Text Key: 203490751
• Report Number: 1226188-2020-00144
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: HRM-5420-28-49
• Device Lot Number: 1304201A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR