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

Model Number	942-01-36G
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as a skin infection.The previous surgery and the surgery detailed in this event occurred 21 days apart.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post-surgical instructions.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 records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices 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 are multiple factors that may contribute to an infection that are outside of the control of djo surgical.With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection.If additional information is submitted at a later time, containment will be re-evaluated.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 - due to skin infection.

• Brand Name: DJO ACETABULAR SYSTEM
• Common Device Name: EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36G
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 11330305
• Report Number: 1644408-2021-00128
• Device Sequence Number: 16402619
• Product Code: LPH
• UDI-Device Identifier: 00190446309772
• UDI-Public: (01)00190446309772
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: 01/27/2025
• Device Model Number: 942-01-36G
• Device Catalogue Number: 942-01-36G
• Device Lot Number: 623Z1007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 02/15/2021
• 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; Required Intervention
• Patient Age: 76 YR