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

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.

• 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 Key: 6260056
• MDR Text Key: 65060693
• Report Number: 3005180920-2016-00744
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• 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 Date: 04/20/2021
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 160222
• 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 Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided; 12/19/2016
• Supplement Dates FDA Received: 04/05/2017; 08/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 78