MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP; LINER 10 DEG. HOODED NEU, MP8 HXE-PLUS, 36MM

Model Number 932-36-754

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 11/22/2017

Event Type  Injury  

Event Description

Revision surgery - due to an infection.The surgeon did a poly exchange.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 16 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.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.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.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: X-ALT HIP
• Type of Device: LINER 10 DEG. HOODED NEU, MP8 HXE-PLUS, 36MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 7105031
• MDR Text Key: 94418404
• Report Number: 1644408-2017-01146
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912100175
• UDI-Public: (01)00888912100175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2021
• Device Model Number: 932-36-754
• Device Catalogue Number: 932-36-754
• Device Lot Number: 814N1949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 400-03-363, LOT 868B1168
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR