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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L. P. BIOLOX DELTA CERAMIC FEMORAL HEAD HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL
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ENCORE MEDICAL L. P. BIOLOX DELTA CERAMIC FEMORAL HEAD HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL Back to Search Results
Model Number 400-03-322
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event or Problem Description
Revision surgery - unknown reason.
 
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Brand Name
BIOLOX DELTA CERAMIC FEMORAL HEAD HIP
Common Device Name
HEAD, FEMORAL, CERAMIC, BILOX DELTA, 32MM NEUTRAL
Manufacturer (Section D)
ENCORE MEDICAL L. P.
9800 metric blvd.
austin TX 78758 5445
MDR Report Key11144100
Report Number1644408-2021-00036
Device Sequence Number630545
Product Code LZO
UDI-Device Identifier00888912076098
UDI-Public(01)00888912076098
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K082844
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/09/2021
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
Operator of Device Health Professional
Device Expiration Date01/29/2025
Device Model Number400-03-322
Device Catalogue Number400-03-322
Device Lot Number861B1191
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2020
Initial Report FDA Received Date01/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age46 YR
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