MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; ACETABULAR SHELL NO-HOLE

Catalog Number 01.26.45.1150

Device Problem Device Issue (2379)

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

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation performed by r&d project manager on 01 december 2017: the image provided by the complainer was checked: after the preliminary investigation, no particular defects in geometry were noticed.In fact the correct design of the cup is not totally symmetric, due to the presence to a shoulder: in the rim area of the superior quadrant of the shell, the rim is thinner due to the presence of a big radius.A further analysis will be performed as soon as the cup returns to medacta international.Batch review performed on 04 december 2017: (b)(4).

Event Description

According to the surgeon and the or staff, the connection hole of the versafictup cc trio no-hole 50 was not central in the cup.The involved cup was not used and another one was opened, same reference but different lot.

Manufacturer Narrative

On dec 15, 2017 the cq manager provided the report of the analysis performed on the retrieved cup with the following conclusion: the dimensional control has not identified any anomaly or defect.The device is conforming to the specifications.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Type of Device: ACETABULAR SHELL NO-HOLE
• 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
• MDR Report Key: 7095626
• MDR Text Key: 95737564
• Report Number: 3005180920-2017-00736
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122911
• 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: 01/12/2018

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
• Device Expiration Date: 01/18/2022
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 165940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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): Other