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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 36 SIZE M 0; METALLIC BALL HEAD
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MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 36 SIZE M 0; METALLIC BALL HEAD Back to Search Results
Catalog Number 01.25.031
Health Effect - Clinical Code Hematoma (1884)
Date of Event 09/06/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2017.Lot 145719: 50 items manufactured and released on (b)(6) 2014.Expiration date: (b)(6) 2019.No anomalies found related to the problem.To date, 44 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in and presented with a hematoma.The surgeon washed out the hip and revised the head.The surgery was completed successfully.
 
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Brand Name
COCR BALL HEAD 12/14 Ø 36 SIZE M 0
Common Device Name
METALLIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key6921441
Report Number3005180920-2017-00552
Device Sequence Number852843
Product Code JDI
UDI-Device Identifier07630030805219
UDI-Public07630030805219
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K080885
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) 10/06/2017
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 Date09/30/2019
Device Catalogue Number01.25.031
Device Lot Number145719
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/06/2017
Initial Report FDA Received Date10/06/2017
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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