MAUDE Adverse Event Report: ENCORE MEDICAL L.P STEM, HIP, FH 450 SERIES SIZE9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 450-01-090

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

Patient Problem Unspecified Infection (1930)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-00524; 450-01-105, 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: STEM, HIP, FH 450 SERIES SIZE9
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 19140543
• MDR Text Key: 340561624
• Report Number: 1644408-2024-00518
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00888912086073
• UDI-Public: 00888912086073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961890
• 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: 04/18/2024

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: 450-01-090
• Device Lot Number: 540C1099
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2022
• 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: 400-03-403 LOT: 873B1287; 941-01-40H LOT: 605Z1208
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male