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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 40MM
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ENCORE MEDICAL L.P BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 40MM Back to Search Results
Model Number 400-04-400
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event or Problem Description
Second revision surgery - patient's cup was loosening.Removed the head, sleeve and cup.Djo replaced the head and sleeve with our product.Cup was replaced with another company.
 
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Brand Name
BIOLOX DELTA HIP
Common Device Name
HEAD, FEMORAL, CERAMIC, BILOX DELTA OPTION HEAD, 40MM
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin,tx 78758-5445
MDR Report Key10836330
Report Number1644408-2020-01043
Device Sequence Number2908546
Product Code LZO
UDI-Device Identifier00888912076265
UDI-Public(01)00888912076265
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K082844
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/13/2020
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 Model Number400-04-400
Device Catalogue Number400-04-400
Device Lot Number884B1054
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/15/2020
Initial Report FDA Received Date11/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
400-05-007 LOT 888B1030
Outcome Attributed to Adverse Event Required Intervention;
Patient Age44 YR
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