MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.1148
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 20 november 2017.Lot 172512: (b)(4) items manufactured and released on 04 august 2017.Expiration date: 2022-07-24.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.Versafitcup flat pe hc liner ø 32 / c, code 01.26.3239hct, lot.172714 (k120531) (b)(4) items manufactured and released on 15 september 2017.Expiration date: 2022-08-28.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 23 november 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the liner was analyzed: some little signs were noticed, but no particular big damages or features were noticed.Moreover, an impaction trial has been done, correctly positioning the liner into a versafitcup cc shell of the related size.The problem could be related to an incorrect alignment of the two axis (cup and liner), preventing the insertion of the liner; in any case, it is not possible to determine with certainty the root cause of the event.
Event or Problem Description
The pe inlay did not want to fit when inserting into the cup.This was achieved even after several tests of the cup and the inlay for foreign bodies or similar.A new inlay with the same size was used, which was then properly fit in the cup.The surgery could then be successfully terminated without problems.The cup was not exchanged.

• Brand Name: VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057107
• Report Number: 3005180920-2017-00693
• Device Sequence Number: 900269
• Product Code: LZO
• UDI-Device Identifier: 07630030807879
• UDI-Public: 07630030807879
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 01.26.45.1148
• Device Lot Number: 172512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other