MAUDE Adverse Event Report: ENCORE MEDICAL L.P. GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL; REVERSE PROSTHESIS SHOULDER SYSTEM

Catalog Number 508-32-101

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

Patient Problem Arthralgia (2355)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00227; 508-36-101, s800 - revision surgery, 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 - mdr - the patient was having acromial impingement.He was too lateralized, so dr.Decided to change glenospheres to a less lateralized one along with a semi-constrained socket.

• Brand Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL
• Type of Device: REVERSE PROSTHESIS SHOULDER SYSTEM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18280053
• MDR Text Key: 329889084
• Report Number: 1644408-2023-01780
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• 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: 12/06/2023

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: 508-32-101
• Device Lot Number: 862C3353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 509-00-032 ,, LOT 377P1586
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male