MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 941-01-36E

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Revision surgery - due to dr.Removed liner & 36 head & reimplant with new dual mobility head.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-01558; 943-01-44i, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36E
• 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: 18882651
• MDR Text Key: 337401970
• Report Number: 1644408-2024-00299
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00190446309512
• UDI-Public: 00190446309512
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 941-01-36E
• Device Lot Number: 597Z1230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2023
• 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
• Treatment: 400-03-361 LOT: 864B1765
• Patient Outcome(s): Required Intervention
• Patient Age: 100 YR
• Patient Sex: Female