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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA VERSAFITCUP CC CUP IMPACTOR; REUSABLE SURGICAL INSTRUMENT FOR HIP
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MEDACTA INTERNATIONAL, SA VERSAFITCUP CC CUP IMPACTOR; REUSABLE SURGICAL INSTRUMENT FOR HIP Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The impactor was stuck in the shell.The surgeon had to change the cup to complete the surgery.(b)(4).
 
Manufacturer Narrative
Batch reviews: from the document review of the lot involved (1110483-218 instruments produced) no anomalies were found.No similar issues have been registered with items of the same lot.Versafitcup cc trio no holes shell ((b)(4)): code (b)(4).1154 lot 144708:(b)(4) shells manufactured and 71 already sold.No anomalies were found from the document review; no similar cases with items of the same lot.The failure mode is unlikely to cause patient harm, even if it can lead to additional steps to fix the problem.
 
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Brand Name
VERSAFITCUP CC CUP IMPACTOR
Type of Device
REUSABLE SURGICAL INSTRUMENT FOR HIP
Manufacturer (Section D)
MEDACTA INTERNATIONAL, SA
castel san pietro
SZ 
Manufacturer (Section G)
MEDACTA INTERNATIONAL, SA
strada regina
castel san pietro 6874
SZ   6874
Manufacturer Contact
adam gross
1556 w carrol ave
chicago, IL 60607
3128782381
MDR Report Key4373098
MDR Text Key5289620
Report Number3005180920-2014-00177
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received 11/07/2014
Initial Date FDA Received12/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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