MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Catalog Number 520-08-021

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

Patient Problem Unspecified Infection (1930)

Event Date 09/25/2023

Event Type  Injury  

Event Description

Revision surgery - infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-01522; 520-12-000, (b)(4)- infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• 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: 17971374
• MDR Text Key: 326123404
• Report Number: 1644408-2023-01478
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00190446648314
• UDI-Public: 00190446648314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193226
• 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: 10/19/2023

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: 520-08-021
• Device Lot Number: 1924A1200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/19/2023
• 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: 520-54-218 LOT: 950U1076
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male