MAUDE Adverse Event Report: ENCORE MEDICAL L.P INSERT, 3D SIZE6 X 13MM L DCM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 391-13-606

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00117; 391-15-705, s814 - stability, poor joint, 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 instability.

• Brand Name: INSERT, 3D SIZE6 X 13MM L DCM
• 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: 18823096
• MDR Text Key: 336738025
• Report Number: 1644408-2024-00213
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020114
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 391-13-606
• Device Lot Number: 53951695
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male