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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP

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MEDACTA INTERNATIONAL, SA TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
(b)(4).
 
Manufacturer Narrative
Batch review performed on (b)(6) 2015: lot #1413789: (b)(4) instruments manufactured and released on (b)(4) 2014.No anomalies found related to the problem.Lot #150076: (b)(4) shells manufactured and released on (b)(4) 2015.No anomalies found related to the problem.To date, (b)(4) shells of the lot have been already sold.On (b)(6) 2015, the (b)(4) made the following analysis upon inspection of the retrieved items: the terminal was manually disengaged from the cup with the screwdriver using a clamp to hold the cup.The contact surfaces between the two items do not present signs of seizing or excessive wear.
 
Manufacturer Narrative
On 07 september 2015 it was prepared a final report with the information already submitted in the initial report.On the same day the report was sent to the initial reporter and the case was closed.
 
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Brand Name
TERMINAL CUP IMPACTOR FOR METAL BACK CC
Type of Device
SURGICAL INSTRUMENT FOR HIP
Manufacturer (Section D)
MEDACTA INTERNATIONAL, SA
castel san pietro
SZ 
Manufacturer (Section G)
MEDACTA INTERNATIONAL, SA
strada regina 6874
castel san pietro
SZ  
Manufacturer Contact
erin baumstark
 
3128782381
MDR Report Key4908860
MDR Text Key6539207
Report Number3005180920-2015-00140
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Type of Report Initial
Report Date 10/07/2015
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 06/10/2015
Initial Date FDA Received07/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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