MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR ACETABULAR, DUAL MOBILITY, METAL LINER, 44G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 951-01-44G

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2023

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

It was reported there was a 25 minute delay in surgery.

Manufacturer Narrative

The agent reported (primary total hip tried using dual mobility could not get the liner to seat.Tried multiple times doctor said the taps were not lining up on the cup.) this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was not completed as intended and there was a thirty-five-minute delay.The implant was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the implant was returned to djo and after further examination, only the metal liner was returned, issue could not be replicated with just the once piece, because of this no error could be determined.A review of 951-01-44g device history record (dhr) revealed the implant, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this implant.Complaint database review showed no previous complaints and there were no indications that this implant has a design or material deficiency.The root cause of this complaint is difficult to determine since the metal liner was the only device that was returned.Because of this no fault could be identified.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: EMPOWR ACETABULAR, DUAL MOBILITY, METAL LINER, 44G
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18450304
• MDR Text Key: 332171470
• Report Number: 1644408-2023-01913
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203557
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 951-01-44G
• Device Lot Number: 2218A1063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male