MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EXPRT HIP; EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 75MM

Model Number 495-00-075

Device Problem Positioning Problem (3009)

Patient Problem Fall (1848)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - the patient fell and the cuff was displaced.Cuff liner and screws were all taken out.

Manufacturer Narrative

1644408-2021-01040 was reassessed and determined to be non-reportable.

• Brand Name: EXPRT HIP
• Type of Device: EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 75MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12532662
• MDR Text Key: 273340185
• Report Number: 1644408-2021-01040
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 00190446153825
• UDI-Public: (01)00190446153825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 495-00-075
• Device Catalogue Number: 495-00-075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 400-03-402 LOT UNKNOWN.; 400-03-402 LOT UNKNOWN
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female