MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ACETABULAR HIP; TRIAL LINER, EMPOWR ACETABULAR, NEUTRAL, 36H

Model Number	803-41-36H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - product failure.Too much torque was put on the instrument and the metal screw popped out of plastic.No pieces remained in patient.

• Brand Name: ACETABULAR HIP
• Common Device Name: TRIAL LINER, EMPOWR ACETABULAR, NEUTRAL, 36H
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11919134
• Report Number: 1644408-2021-00489
• Device Sequence Number: 16970120
• Product Code: LPH
• UDI-Device Identifier: 00190446296300
• UDI-Public: (01)00190446296300
• 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: 2021
• 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): 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 803-41-36H
• Device Catalogue Number: 803-41-36H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other