MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM -4.0

Model Number 400-03-361

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient presented with an abscess, so cup, liner and head were removed and replaced.Stem was left in the body.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 4 months apart.The healthcare professional indicated that there was a significant adverse event to patient.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 the hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component 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 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 devices were 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.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: BIOLOX DELTA HIP
• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM -4.0
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10913769
• MDR Text Key: 218510836
• Report Number: 1644408-2020-01094
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00888912076128
• UDI-Public: (01)00888912076128
• Combination Product (y/n): N
• PMA/PMN Number: K082844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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
• Device Operator: Health Professional
• Device Model Number: 400-03-361
• Device Catalogue Number: 400-03-361
• Device Lot Number: 864B1457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR