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

Model Number	495-00-075
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - the patient fell and the cuff was displaced.Cuff liner and screws were all taken out.
Additional Manufacturer Narrative
1644408-2021-01040 was reassessed and determined to be non-reportable.

• Brand Name: EXPRT HIP
• Common Device Name: 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
• Report Number: 1644408-2021-01040
• Device Sequence Number: 13786896
• Product Code: KWZ
• UDI-Device Identifier: 00190446153825
• UDI-Public: (01)00190446153825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-402 LOT UNKNOWN.; 400-03-402 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female