MAUDE Adverse Event Report: ENCORE MEDICAL L.P EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 65MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number 495-00-065

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2018-01025; 495-00-065, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - due to infection.

• Brand Name: EXPRT REVISION HIP, STANDARD OFFSET PROXIMAL BODY, 65MM
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18576963
• MDR Text Key: 333659475
• Report Number: 1644408-2024-00017
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 00190446153818
• UDI-Public: 00190446153818
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 495-00-065
• Device Lot Number: 539U1142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 871B1417
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female