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 Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Revision surgery - due to dislocation and infection.

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(infection was suspected and patient had dislocated.A washout was done.The neck and stem are a kit, but only the neck came out and the stem stayed in.There is no separate part number for the neck)".The previous surgery and the surgery detailed in this event occurred 30 days apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for review.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection and dislocation.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the possible infection or inhibited the patient's immune system.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post-surgical instructions.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.

• 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: 18882648
• MDR Text Key: 337401935
• Report Number: 1644408-2024-00266
• 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: 03/11/2024

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: 520-08-021
• Device Lot Number: 1924A1357
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2023
• 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: 520-46-216 LOT: 948U1232
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female