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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 04/23/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018.Lot 176024: (b)(4) items manufactured and released on 12 december 2017.Expiration date: 2022-11-16 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.Versafitcup dm double mobility hc liner ø 52/28 reference 01.26.2852mhc (k092265) lot 177528: (b)(4) items manufactured and released on 20 february 2018.Expiration date: 2023-02-04 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
Revision due to signs of infection 2 weeks after primary.The pathogen is unknown.The surgeon revised the head and liner 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, switzerland 6874
SZ  6874
MDR Report Key7540695
Report Number3005180920-2018-00356
Device Sequence Number1818750
Product Code JDI
UDI-Device Identifier07630030805110
UDI-Public07630030805110
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K072857
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/24/2018
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 Date11/16/2022
Device Catalogue Number01.25.012
Device Lot Number176024
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 04/24/2018
Initial Report FDA Received Date05/24/2018
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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