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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE M 0
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MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE M 0 Back to Search Results
Catalog Number 01.25.012
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 12/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 january 2018: lot 168271: (b)(4) items manufactured and released on 04 may 2017.Expiration date: 2022-04-23 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.Bipolar head ø28x44 reference 25060.2844 (k091967): lot.171298: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-06-06 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 due to signs of infection.The pathogen is unknown.The surgeon revised the head and liner.The surgery was completed successfully.
 
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Brand Name
COCR BALL HEAD 12/14 Ø 28 SIZE M 0
Common Device Name
COCR BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7206119
Report Number3005180920-2017-00859
Device Sequence Number16367771
Product Code JDI
UDI-Device Identifier07630030805110
UDI-Public07630030805110
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K072857
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/19/2018
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 Date04/23/2022
Device Catalogue Number01.25.012
Device Lot Number168271
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2017
Initial Report FDA Received Date01/19/2018
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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