MAUDE Adverse Event Report: ENCORE MEDICAL L.P. X-ALT HIP; HEAD, FEMORAL, METAL-METAL 38MM NEUTRAL

Catalog Number 497-38-000

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.

Event Description

Revision surgery the reason for revision was due to the patient having metal on metal, which was causing metalosis.Removed and exchanged out the sleeve, head and liner.

Manufacturer Narrative

The reason for this revision surgery was reported as metallosis.The previous surgery and the surgery detailed in this event occurred 12 years and 8 months 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 metallosis.There were no findings during this evaluation that indicate the reported devices were 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 poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: X-ALT HIP
• Type of Device: HEAD, FEMORAL, METAL-METAL 38MM NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9636739
• MDR Text Key: 176657422
• Report Number: 1644408-2020-00030
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912087339
• UDI-Public: (01)00888912087339
• Combination Product (y/n): N
• PMA/PMN Number: K072154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 497-38-000
• Device Lot Number: 53849927
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 411-00-000 LOT 53845883; 499-38-009 LOT 53846340; 411-00-000 LOT 53845883; 499-38-009 LOT 53846340
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR