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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L
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MEDACTA INTERNATIONAL SA BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L Back to Search Results
Model Number 01.29.214
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on 29 may 2020: lot 1900813: (b)(4) items manufactured and released on 15-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in 6 days after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the medacta head with a medacta head and another company's liner with a competitor's liner.The surgery was completed successfully.
 
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Brand Name
BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L
Common Device Name
CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key10157886
Report Number3005180920-2020-00340
Device Sequence Number11469055
Product Code LZO
UDI-Device Identifier07630030809255
UDI-Public07630030809255
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K112115
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/16/2020
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 No Information
Device Expiration Date05/05/2024
Device Model Number01.29.214
Device Catalogue Number01.29.214
Device Lot Number1900813
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/19/2020
Initial Report FDA Received Date06/16/2020
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;
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