MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number 521-07-250

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

Patient Problems Limb Fracture (4518); Insufficient Information (4580)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00386; 521-07-254, s807 - pain, 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 rotator cuff tear and serious risk to patient.

• Brand Name: ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, E-PLUS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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: 18727832
• MDR Text Key: 335707553
• Report Number: 1644408-2024-00115
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162024
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 521-07-250
• Device Lot Number: 893U1127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2020
• 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: 520-07-000 LOT: 888U1447; 520-12-000 LOT: 852U1388; 520-50-318 LOT: 958U1109
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male