MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO EMPOWR KNEETM, PRESS FIT BP MINUS, 7L; MACHINED, DJO EMPOWR KNEETM

Catalog Number 353-03-107

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

Patient Problems Arthralgia (2355); Joint Laxity (4526)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2021-01317; 353-02-106, s810 - device loosening, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - mdr - loosening/pain.

• Brand Name: DJO EMPOWR KNEETM, PRESS FIT BP MINUS, 7L
• Type of Device: MACHINED, DJO EMPOWR KNEETM
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18088694
• MDR Text Key: 327588157
• Report Number: 1644408-2023-01554
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00190446230250
• UDI-Public: 00190446230250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171991
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 353-03-107
• Device Lot Number: 212W1027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 243-01-107 , LOT 276W1114.; 341-10-707 , LOT 067T1093.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female