MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP STANDARD HUMERAL SOCKET INSERT, 40MM, HXE-PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	509-00-040
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - infection.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2023-00204; 509-00-036, 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: RSP STANDARD HUMERAL SOCKET INSERT, 40MM, HXE-PLUS
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19347910
• Report Number: 1644408-2024-00695
• Device Sequence Number: 20456118
• Product Code: PHX
• UDI-Device Identifier: 00888912144551
• UDI-Public: 00888912144551
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 509-00-040
• Device Lot Number: 379P1156A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-02-134 LOT: 828C1947; 506-02-138 LOT: 830C1938A; 506-03-130 LOT: 835C2201; 506-03-134 LOT: 836C1512; 508-32-204 LOT: 769P2984; 508-40-101 LOT: 875C1395; 510-08-000 LOT: 142G1413; 530-12-108 LOT: 412T1657
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male