MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 44J; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 941-01-44J

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

Patient Problem Joint Laxity (4526)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-02012; 942-01-40h, s810 - device loosening, 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 - due to loosening.

• Brand Name: EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 44J
• 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: 18852888
• MDR Text Key: 337068696
• Report Number: 1644408-2024-00243
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00190446309642
• UDI-Public: 00190446309642
• 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: 03/06/2024

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 Catalogue Number: 941-01-44J
• Device Lot Number: 610Z1008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2020
• 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: 400-03-443 LOT: 878B1195; 450-01-120 LOT: 544C1082; 940-00-045 LOT: 150Z1047; 940-02-62I LOT: 805Z1043
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male