MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; SOCKET, INSERT 36MM STD. RSP HUMERAL

Model Number 508-00-000

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Code Available (3191)

Event Date 12/20/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient developing symptoms of an infection.An irrigation and debridement was preformed where the shell, liner and glenoid head were replaced.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 7.7 years 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 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: SOCKET, INSERT 36MM STD. RSP HUMERAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8250582
• MDR Text Key: 133142320
• Report Number: 1644408-2019-00023
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024600
• UDI-Public: (01)00888912024600
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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: 03/28/2016
• Device Model Number: 508-00-000
• Device Catalogue Number: 508-00-036
• Device Lot Number: 856C1013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-00-000, LOT 848C1100; 508-00-036, LOT 856C1013; 508-36-101, LOT 869C1028; 508-36-101, LOT 869C1028; 508-00-036, LOT 856C1013; 508-36-101, LOT 869C1028
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR