MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, HXE-PLUS; REVERSE PROSTHESIS SHOULDER SYSTEM

Catalog Number 509-01-036

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

Patient Problem Arthralgia (2355)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2018-01194; 509-01-032, 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 - mdr - pain.

• Brand Name: RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, HXE-PLUS
• 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: 17946776
• MDR Text Key: 325798487
• Report Number: 1644408-2023-01436
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144629
• UDI-Public: 00888912144629
• 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: 10/16/2023

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: 509-01-036
• Device Lot Number: 382P1039
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female