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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 Date 03/10/2015
Event Type  malfunction  
Event Description
Imp ref#: (b)(4).
 
Manufacturer Narrative
The lot of the instrument is unk and we are waiting for the retrieved items to make it available.Batch review performed on 04/09/2015 on the lot of the shell: lot 145994: (b)(4) shells produced and released on 11/17/2014.No anomalies found related to the problem.To date, (b)(4) shells of the lot have been already sold without any similar issue.
 
Manufacturer Narrative
On 07/02/2015 it was prepared a final report with the information collected during the investigation, already reported in the initial report and in the first follow up.On 07/09/2015 the report was sent to the initial reporter and the case was closed.
 
Manufacturer Narrative
Additional information: on 04/20/2015 the retrieved items have been disassembled and the lot of the instrument has been detected: 1213128.On this date, the r and d project manager analyzed the items with the following outcomes: the terminal was blocked into the cup because the thread was damaged likely due to a hit.The damaged thread compromises the coupling with the cup.
 
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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 Contact
erin baumstark
strada regina
castel san pietro 6874
SZ   6874
3128782381
MDR Report Key4707571
MDR Text Key21118611
Report Number3005180920-2015-00052
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 Distributor
Type of Report Initial
Report Date 04/09/2015
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/10/2015
Initial Date FDA Received04/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
VERSAFITCUP CC TRIO ACETABULAR SHELL:; K103352, CODE: 01.26.45.0058, LOT: 145994
Patient Outcome(s) Other;
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