MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXE-PLUS

Model Number 509-00-432

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 01/12/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient showing signs of infection, 1 month post operative.She was treated with antibiotics, which seemed to work, however, recently the patient came back.The surgeon opted to do an irrigation and drainage (i&d) with insert and glenoid head swap.The patient is a heavy smoker, non-compliant, and an iv drug abuser.

Manufacturer Narrative

The reason for this revision surgery was due to an infection.The previous surgery and the revision detailed in this investigation occurred 58 days apart.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 infection or inhibited the patient's immune system.Initial or prolonged hospitalization was required.The healthcare professional indicated there was a serious risk to the patient and that it was a life-threatening event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Type of Device: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXE-PLUS
• 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: teffany hutto ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 7205370
• MDR Text Key: 97730005
• Report Number: 1644408-2018-00051
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912144575
• UDI-Public: (01)00888912144575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: 509-00-432
• Device Catalogue Number: 509-00-432
• Device Lot Number: 385P1094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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
• Treatment: 508-32-103, LOT 864C2782
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 61 YR