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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

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MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56 Back to Search Results
Catalog Number 01.26.45.0056
Device Problems Microbial Contamination of Device (2303); Device Operates Differently Than Expected (2913)
Patient Problem Unspecified Infection (1930)
Event Date 12/19/2016
Event Type  Injury  
Manufacturer Narrative
Additional information received from the initial reporter on 09 january 2016 and includes: the intra-operative swabs pathology results showed staphylococcus epidermidis (gram positive) infection.Batch reviews performed on 16 january 2017.Lot 160222: (b)(4) items manufactured and released on 04 may 2016.Expiration date: 2021-04-20.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.Cancellous bone screw flat head ø 6,5 l 30, code 01.26.65.30, lot.153635 (k103352) (b)(4) items manufactured and released on 09 september 2015.Expiration date: 2020-06-30.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.Flat pe hc liner ø 32 / f, code 01.26.3248hct, lot.147155 (k103352) (b)(4) items manufactured and released on 02 december 2014.Expiration date: 2019-10-31.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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size s -4, code 01.29.204, lot.163449 (k112115) (b)(4) items manufactured and released on 05 september 2016.Expiration date: 2021-08-24.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.Quadra-h cementless, ha coated std stem size 3, short neck, code 01.12.23sn, lot.151869 (k082792) (b)(4) items manufactured and released on 03 august 2015.Expiration date: 2020-07-13.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.On 18 january 2017 the r&d project manager performed a preliminary investigation based on the images received by the reporter and commented as follows: the images were analyzed.No particular signs were noticed on the implants, that revealed to be in good conditions.Evident presence of blood and physiological tissue was present on the cup; also blood was present inside the liner and on the ceramic ball head, once explanted.In the stem the ha coating and blood were well evident on the entire body.From the received images it was not possible to determine the root cause of the event.
 
Event Description
Revision of a cup, screw, liner, head and stem as the patient had presented with signs of infection.This was a first stage revision to be finalised in approximately 4 weeks once the infection has cleared.A cemented spacer was implanted along with temporary cemented stem and a metal head.The intra-operative swabs pathology results showed staphylococcus epidermidis (gram positive) infection.X-rays available.
 
Manufacturer Narrative
Additional information received on 06 march 2017 and includes: the explanted items were not available.Not available.
 
Manufacturer Narrative
Additional information received on 31 july 2017 and includes: the surgeon performed the second step of this revision case on (b)(4) 2017.This was the final stage of revision following a first stage revision performed due to infection.As per the available images, the explanted ceramic liner was cemented in as a temporary acetabular spacer during the 1st stage revision, as was the explanted stem.The infection is now assessed as cleared based on surgeon observation.Pathology results will be provided for confirmation once available.On 17 august 2017 the r&d project manager updated the preliminary investigation based on the new, available images and commented as follows: based on the pictures, nothing can be commented, especially, nothing that would change the final root cause.
 
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Brand Name
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
Type of Device
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ   6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
91 6966060
MDR Report Key6260056
MDR Text Key65060693
Report Number3005180920-2016-00744
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K103352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 08/30/2017
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
Device Operator Health Professional
Device Expiration Date04/20/2021
Device Catalogue Number01.26.45.0056
Device Lot Number160222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/19/2016
Initial Date FDA Received01/18/2017
Supplement Dates Manufacturer ReceivedNot provided
12/19/2016
Supplement Dates FDA Received04/05/2017
08/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight78
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