MAUDE Adverse Event Report: ENCORE MEDICAL L.P AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 509-02-032

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

Patient Problems Unspecified Infection (1930); Implant Pain (4561)

Event Date 03/27/2024

Event Type  Injury  

Event Description

Revision surgery: due to pain and infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-01014; 509-02-032, s807 - pain, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 19177642
• MDR Text Key: 340999883
• Report Number: 1644408-2024-00552
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00190446257554
• UDI-Public: 00190446257554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172351
• 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: 04/24/2024

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: 509-02-032
• Device Lot Number: 951W2114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2023
• 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: 506-03-114 LOT: 831C2303.; 506-03-130 LOT: 835C2056.; 508-32-101 LOT: 862C3904.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 87 KG