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

Model Number	509-01-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery due to infection.
Additional Manufacturer Narrative
See d4 expiration date, h4 and h5.The reason for this revision surgery, the agent reported "(infected patient 2 stage revision.Antibiotic spacer placed)".The previous surgery and the surgery detailed in this event occurred 10 months and 2 weeks apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.First, there was a ncmr#: (b)(4) associated with the main part #: 510-08-000, rsp spacer w/retaining screw, which documents that out of 20 parts lot, 4 parts were rejected due to blast not uniform inside or scratches on blast.Later the rejected parts were reworked and accepted after proper justification.Second, there was a ncmr#: (b)(4) associated with the main part#: 508-40-101, glenoid, head w/retaining screw, rsp, 40mm, neutral, which documents that out of 15 parts lot, all parts were rejected due to tool marks on inside taper.Later the rejected parts were found with no defects and accepted after proper justification.All other items in the respective lot were met with the design, fit and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.

• Brand Name: RSP SEMICONSTRAINED 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: 16401926
• Report Number: 1644408-2023-00161
• Device Sequence Number: 12166883
• Product Code: PHX
• UDI-Device Identifier: 00888912144636
• UDI-Public: 00888912144636
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2026
• Device Model Number: 509-01-040
• Device Catalogue Number: 509-01-040
• Device Lot Number: 383P1067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 506-03-114 LOT: 831C2042.; 506-03-114 LOT:831C2021.; 506-03-130 LOT: 835C1877.; 506-03-134 LOT: 836C1397.; 508-32-204 LOT: 769P2244.; 508-40-101 LOT: 875C1315.; 510-08-000 LOT: 142G1361.; 530-10-108 LOT: 409T1708.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male