MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR HIP; EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36E

Model Number	942-01-36E
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - the patient was thought to have an infection.The surgeon opened the patients incision and there was a hematoma.The surgeon cleaned out the joint and replaced the femoral head and liner.
Additional Manufacturer Narrative
Additional narrative: see g1 - new contact for encore medical l.P.The reason for this revision surgery was due to an infection.The previous surgery and the surgery detailed in this event occurred 34 days apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the device history record show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to an infection.There were no findings during this evaluation that indicate that the reported device was the source or had a direct connection with the patient's infection.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: EMPOWR HIP
• Common Device Name: EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36E
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 11332462
• Report Number: 1644408-2021-00111
• Device Sequence Number: 19478308
• Product Code: LPH
• UDI-Device Identifier: 00190446309758
• UDI-Public: (01)00190446309758
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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 Expiration Date: 10/09/2025
• Device Model Number: 942-01-36E
• Device Catalogue Number: 942-01-36E
• Device Lot Number: 621Z1024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-362 LOT 866B1632; 400-03-362 LOT 866B1632
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR