MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, SOLID BACK, 54

Catalog Number	940-01-54G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to loosening.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-00998, 940-01-56h, s810 - device loosening, revision surgery.Surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR HIP
• Common Device Name: EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, SOLID BACK, 54
• 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: 18237183
• Report Number: 1644408-2023-01747
• Device Sequence Number: 16950765
• Product Code: LPH
• UDI-Device Identifier: 00190446311423
• UDI-Public: (01)00190446311423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 940-01-54G
• Device Lot Number: 786Z1029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-363 LOT 868B1556.; 941-01-36G LOT 599Z1145.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female