BIOLOX DELTA HIP 400-03-363

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for BIOLOX DELTA HIP 400-03-363 manufactured by Encore Medical L.p..

Event Text Entries

[186537281] The reason for this revision surgery was reported as an infection. The previous surgery and the surgery detailed in this event occurred 28 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 not made available to djo surgical for examination. 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 was no non-conforming material report (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 the reported device 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 the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
Patient Sequence No: 1, Text Type: N, H10


[186537304] Revision surgery - incision and drainage washout. Early infection. Swapped poly and head.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2020-00255
MDR Report Key9905107
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-30
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-10-21
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOLOX DELTA HIP
Generic NameHEAD, FEMORAL, CERAMIC, BILOX DELTA, 36MM +4.0
Product CodeLZO
Date Received2020-03-31
Model Number400-03-363
Catalog Number400-03-363
Lot Number868B1320
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN, TX 78758-5445, US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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