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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L; HIP CERAMIC BALL HEAD
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MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L; HIP CERAMIC BALL HEAD Back to Search Results
Catalog Number 01.29.203
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 june 2019: lot 176812: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
 
Event or Problem Description
Revision surgery performed after 1 month from the primary due to an infection (the pathogen is unknown).The surgeon revised the head and liner.The surgery was completed successfully.
 
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Brand Name
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L
Common Device Name
HIP CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8797314
Report Number3005180920-2019-00576
Device Sequence Number16227126
Product Code LZO
UDI-Device Identifier07630030809149
UDI-Public07630030809149
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K112115
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/17/2019
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 Date03/13/2023
Device Catalogue Number01.29.203
Device Lot Number176812
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2019
Initial Report FDA Received Date07/17/2019
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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