MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. ENCORE SHOULDER; ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X175MM

Catalog Number 530-06-175

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/06/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient having an infection.

Manufacturer Narrative

The reason for this revision surgery was infection.The previous surgery and the revision detailed in this investigation occurred 2 months 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.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to an infection.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 (dhr), product complaint report (pcr) database, and sterilization records 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.The device was verified to have gone through an acceptable sterilization process and was within its 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: ENCORE SHOULDER
• Type of Device: ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ6X175MM
• 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: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5536300
• MDR Text Key: 41490180
• Report Number: 1644408-2016-00160
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141990
• 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: 03/06/2016

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: 11/23/2021
• Device Catalogue Number: 530-06-175
• Device Lot Number: 404T1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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 864C1982
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR