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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
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MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L Back to Search Results
Catalog Number 01.29.203
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 186532: (b)(4) items manufactured and released on 29 november 2018.Expiration date: 2023-11-13.No anomalies found related to the issue.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, one month after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and 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
CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8703933
Report Number3005180920-2019-00471
Device Sequence Number16662327
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) 06/17/2019
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 Date11/13/2023
Device Catalogue Number01.29.203
Device Lot Number186532
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/19/2019
Initial Report FDA Received Date06/17/2019
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;
Patient Age80 YR
Patient Weight83
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