MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIGHLY HIP; LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM

Model Number	932-32-750
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacture narrative: the reason for this revision surgery was reported as patient was draining.The previous surgery and the surgery detailed in this event occurred 2 months and 4 days apart.The healthcare professional indicated there was a significant adverse event.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was discarded by the hospital and 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 report (ncmr) associated with the products that may have contributed to the reported event.The devices were 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 draining.There were no findings during this evaluation that indicate that the reported device was defective.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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as inadequate soft tissue support, poor bone density, patient bone deterioration, incorrect implant selection, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - due to patient draining.
Additional Manufacturer Narrative
Corrected data: see d4.

• Brand Name: X-ALT HIGHLY HIP
• Common Device Name: LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 9391997
• Report Number: 1644408-2019-01163
• Device Sequence Number: 2423726
• Product Code: LPH
• UDI-Device Identifier: 00888912100045
• UDI-Public: (01)00888912100045
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 10/11/2022
• Device Model Number: 932-32-750
• Device Catalogue Number: 932-32-750
• Device Lot Number: 811N1948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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: 400-04-320, LOT 882B1070.; 400-05-004, LOT 887B1071.
• Outcome Attributed to Adverse Event: Required Intervention