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

Model Number 509-00-036

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as potential infection.The previous surgery and the surgery detailed in this event occurred 34 days apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.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.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 reported as a potential infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's potential 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 potential infection or inhibited the patient's immune system.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 presented to surgeon with pain and redness surrounding the surgical wound.Upon further testing and work-up the patient was suspected to have a potential infection and was scheduled for a irrigation and debridement procedure where the implants were removed and replaced.

• Brand Name: RSP
• Type of Device: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, 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: 9873445
• MDR Text Key: 186137040
• Report Number: 1644408-2020-00245
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144544
• UDI-Public: (01)00888912144544
• 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: 03/23/2020

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 Model Number: 509-00-036
• Device Catalogue Number: 509-00-036
• Device Lot Number: 378P1257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• 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: 62 YR
• Patient Weight: 67