MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL

Catalog Number 508-36-101

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

Patient Problem Joint Laxity (4526)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Revision surgery - patient presented with instability.Surgeon decided to revise using a 40 neutral glenosphere.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00170, 508-36-103, 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.

• Brand Name: RSP
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• 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: 18237184
• MDR Text Key: 329368085
• Report Number: 1644408-2023-01742
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024761
• UDI-Public: (01)00888912024761
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C4060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female