MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 40H

Model Number 942-01-40H

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Complaint - during surgery, two hip liner implant boxes were consecutively opened to find empowr 3d knee inserts in the boxes.Surgeon wanted to use a 40mm, 10 degree liner, but was unable.Surgeon had to implant the 40mm non-hooded liner instead.

Manufacturer Narrative

The reason for this complaint was reported as wrong implant selection during surgery.The healthcare professional indicated that this event occurred during surgery, away from the patient.Significant adverse event was reported by the surgeon.There was a ten (10) minute delay in surgery but the surgery was completed as intended.The agent was present during surgery and did not have another suitable device available.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the device history records indicate: twenty (20) pieces of 942-01-40h, acetabular liner, lot 629z1085, were processed on work order (b)(4).These parts went through the sterilizer under sterilization run e220406aaa.Twenty (20) pieces of 341-14-709, knee insert, lot 132t1085, were processed on work order (b)(4).These parts went through the sterilizer under sterilization run e220406aaa.Both work orders were processed by the same operator.The label on the bottom tray matches the work order and packaged part; however, the label on the front of the tray and outer packaging were swapped.A review of the complaint database indicates one other instance occurring for the same product and lot numbers.The surgery took place on the same day.The root cause of this complaint is likely due to the product being switched after the sterilization process.Hhe-2022-00007 was opened to capture the containment process for this issue.Rma examination: the reported devices were returned to djo surgical for evaluation.It is confirmed that the packaging for the acetabular liner contained a empowr 3d knee insert.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR HIP
• Type of Device: EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 40H
• 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: 14780969
• MDR Text Key: 295049719
• Report Number: 1644408-2022-00831
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00190446309833
• UDI-Public: (01)00190446309833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190057
• 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: 06/22/2022

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: 942-01-40H
• Device Catalogue Number: 942-01-40H
• Device Lot Number: 629Z1085
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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: 341-14-708 LOT 132T1085; 341-14-708 LOT 132T1085
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male