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
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ACETABULAR SHELL NO-HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7095626
• Report Number: 3005180920-2017-00736
• Device Sequence Number: 1272653
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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