MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, MULTI HOLE, 52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	940-03-52F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-01236; 940-01-50e, s800 - revision surgery, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to fracture.

• Brand Name: EMPOWR ACETABULAR SYSTEM, CUP, HEMISPHERICAL, MULTI HOLE, 52
• Common Device Name: 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: 18804608
• Report Number: 1644408-2024-00162
• Device Sequence Number: 7231335
• Product Code: LPH
• UDI-Device Identifier: 00190446311720
• UDI-Public: 00190446311720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• 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): 02/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 940-03-52F
• Device Lot Number: 815Z1008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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: 400-04-280 LOT: 881B1103.; 400-05-000 LOT: 886B1285.; 940-00-025 LOT: 146Z1181.; 940-00-025 LOT: 146Z1181.; 940-00-035 LOT: 148Z1064.; 940-00-035 LOT: 148Z1125.; 940-00-035 LOT: 148Z1150.; 951-01-42F LOT: 2217A1052.; 952-28-42F LOT: 2225A1036.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female