MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC HOODED PE HC FIXED LINER Ø 32 / E; ACETABULAR HC PE LINER

Catalog Number 01.26.3244HCAT

Device Problems Disconnection (1171); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on (b)(6) 2015: lot 148366 (two liners of the same lot involved in the case): (b)(4) items manufactured and released on 25 february 2015.Expiration date: 2020-01-31.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.Versafitcup cc trio acetabular cup - code (b)(4), lot 151066 ((b)(4)): lot 151066: (b)(4) items manufactured and released on 22 may 2015.Expiration date: 2020-03-31.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.On (b)(6) 2015 cq department performed a pieces evaluation measuring all dimensions that would have been involved into a coupling failure between cup and liner: all dimensions measured are in compliance with the drawing except for the angle, specified in the drawing as (b)(4) in only one liner.Both pieces are damaged and have some superficial dent, probably, due to the liner extraction from the cup in or.Given that the measures done could be conditioned.On (b)(6) 2015 the sales rep.Confirmed that the surgeon used the wrong impactor only suitable for the ceramic liners and not the one for pe liners.On (b)(6) 2015 the (b)(6) inspected the retrieved liners with the following comments: observing the 2 liners some scratches can be seen on both the external conical surface and the bottom of them: that could be due to the extraction of them from the shell.No anomalies were found related to the lots involved in the claim (see the attached 'batch review').The dimensional controls on the returned liner ((b)(4)) showed that all the specifications required for the coupling between liner and shell were conforming to the drawings, except for the angle of the external conical surface.That could be due to the trials made to impact the liner in the shell.The dimensional controls on the returned liner ((b)(6)) showed that all the specifications required for the coupling between liner and shell were conforming to the drawings.Moreover, the instrument used to impact the liner in the shell was not the correct one indicated in the relative surgical technique; the instrument used can cause problems of aligning between the cone of the liner and the cone of the shell.It is not possible from the inspection of the implants determine the root cause of the event.

Event Description

Liner would not fully seat in the shell.After multiple attempts to seat the liner it remained proud by 1mm.The surgeon tried with two pe hc liners observing the same problem.At the end, a ceramic liner was used without problem.The surgeon said to have seen a discontinuity inside the cup, probable cause of the event.

Manufacturer Narrative

On 21 dec 2015 it was prepared a final report with the information already submitted in the initial report.On 21 dec 2015 the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP CC HOODED PE HC FIXED LINER Ø 32 / E
• Type of Device: ACETABULAR HC PE LINER
• 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: 5168866
• MDR Text Key: 29311166
• Report Number: 3005180920-2015-00242
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 01.26.3244HCAT
• Device Lot Number: 148366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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 Age: 65 YR
• Patient Weight: 80