MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNE; EMPOWR 3DKNEETM INS,6L 10MM, VE

Model Number 341-10-706

Device Problems Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - an infection resulted in the removal of primary knee components and the implantation of an antibiotic spacer, to help the infection heal.The knee is to be revised at a later date.

Manufacturer Narrative

Corrected data: initial medical device report (mdr) reported g.3.Date received by manufacturer as 04-mar-2021.08-mar-2021 is the correct date received by manufacturer for the initial mdr.Manufacturer narrative: the reason for this revision surgery was an infection.The previous surgery and the surgery detailed in this event occurred 2.2 years apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported 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 device history record(s) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an 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 infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There were no findings during this evaluation that indicate that the reported device was the source or had a direct connection with the patient's infection.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: EMPOWR 3D KNE
• Type of Device: EMPOWR 3DKNEETM INS,6L 10MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11614869
• MDR Text Key: 243798684
• Report Number: 1644408-2021-00267
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888912166836
• UDI-Public: (01)00888912166836
• Combination Product (y/n): N
• PMA/PMN Number: K143242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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: 08/23/2023
• Device Model Number: 341-10-706
• Device Catalogue Number: 341-10-706
• Device Lot Number: 066T1070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 241-01-107 LOT 940R1197.; 352-03-106 LOT 318V1003.; 354-12-040 LOT 105Y1005.; 600-15-100, LOT 438720.; 241-01-107 LOT 940R1197; 352-03-106 LOT 318V1003; 354-12-040 LOT 105Y1005
• Patient Outcome(s): Required Intervention