MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP; RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS

Model Number 509-00-436

Device Problem Unstable (1667)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 30 days apart.No other 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.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 components 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.The root cause of this complaint was reported as an infection.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's infection.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post surgical instructions.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - patient came to follow-up at the clinic a couple days prior to removal and presented with instability and localized drainage at incision site.Patient has history of localized infection of the knee post-operation.Decision was made to explant devices.

• Brand Name: RSP
• Type of Device: RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758
• 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: 8800648
• MDR Text Key: 151408397
• Report Number: 1644408-2019-00672
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144582
• UDI-Public: (01)00888912144582
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

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 Expiration Date: 02/25/2024
• Device Model Number: 509-00-436
• Device Catalogue Number: 509-00-436
• Device Lot Number: 386P1096
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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: 61 YR