MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP; LINER/NON-HOODED-NEU, MP9, HXE-PLUS, 40MM

Model Number	931-40-756
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
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
Revision surgery: patient suffered a post-operation infection and was brought in for a washout with an exchange of the ceramic head and poly liner.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 14 days apart.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 disposed of at hospital and n not made available to djo surgical for examination.This evaluation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.A review of the device history record (dhr) 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 (ncmr) 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 reported as an infection.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.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 possible 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.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.

• Brand Name: X-ALT HIP
• Common Device Name: LINER/NON-HOODED-NEU, MP9, HXE-PLUS, 40MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9416567
• Report Number: 1644408-2019-01209
• Device Sequence Number: 2450856
• Product Code: OQG
• UDI-Device Identifier: 00888912099783
• UDI-Public: (01)00888912099783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 08/22/2024
• Device Model Number: 931-40-756
• Device Catalogue Number: 931-40-756
• Device Lot Number: 763N2036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: 400-03-402 LOT 871B1195; 400-03-402 LOT 871B1195
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR