MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54

Catalog Number 01.26.45.0054

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 10 april 2018; lot 174454: (b)(4) items manufactured and released on 10 october 2017.Expiration date: 2022-11-01; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event instruments used: reference 01.15.10.0261 terminal cup impactor for metal back cc lot 1413789: (b)(4) items manufactured and released on 15 december 2014.No anomalies found related to the problem.To date, this is the 6th similar event reported on items of the same lot reference 01.26.10.0062 versafitcup cc cup impactor lot 1414049; (b)(4) items manufactured and released 15 april 2015; no anomalies found related to the issue.To date, no similar event on the same lot has been registered.

Event Description

During final implant impaction, the cup adaptor became loose from the implant and therefore was not able to be used.The surgeon tried with the ref 01.26.10.0162 long straight multifunction handle, but these also became loose from the cup.He believed that the implant thread was damaged and therefore instrument thread would no longer hold it.Then, he removed the cup with the straight cup impactor (ref 01.26.10.0062) and it remained stuck with the implant.He took another cup (same ref, but lot 175392) that was successfully implanted with the first offset handle (coupled with ref 01.15.10.0261) used by the surgeon.No patient harm.

Manufacturer Narrative

Visual inspection performed by r&d product manager on 14 june 2018.During the analysis it is evaluated that the handle is screwed and blocked inside the cup.We have unscrewed the handle thanks to our production department.We notice that the terminal of the threaded part of the handle is broken and in addition the balint coating is scratched on the handle and it is present on the cup surface too.It seems that the user screwed the cup not completely and this caused the breakage of the threaded part and the block into the cup.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7425009
• MDR Text Key: 105886409
• Report Number: 3005180920-2018-00232
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (y/n): N
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 174454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR