MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 1; PROSTHESIS, TOTAL ANATOMIC SHOULDER

Catalog Number 520-08-018

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

Patient Problems Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 07/28/2023

Event Type  Injury  

Event Description

Revision surgery - due to pain and limited range of motion.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-01661; 520-08-021, s807 - pain, 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 1
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER
• 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: 17600260
• MDR Text Key: 321712201
• Report Number: 1644408-2023-01129
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 00190446648307
• UDI-Public: 00190446648307
• 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: 08/22/2023

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: 520-08-018
• Device Lot Number: 1923A1101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/22/2023
• 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: 520-50-218 LOT: 949U1187.; 521-07-242 LOT: 891U1203A.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female