MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC LINER; ACETABULAR PE LINER

Catalog Number	01.26.2839HCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 179303: (b)(4) items manufactured and released on 10 april 2018.Expiration date: 2023-03-20.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During the surgery the insert didn't couple the cup.The surgeon implanted successfully a new liner of the same reference.
Additional Manufacturer Narrative
Metrological analysis performed by quality control manager on 29 august 2018: from the documentation of lot, don't emerge anomalies; the whole dossier of manufacture is conforming to the specific project.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project visual inspection performed on 26 september 2018: pe liner dimensional analysis has been requested.Dimensional analysis did not reveal any quote out of tolerance.It is not possible to determine a device related root cause.

• Brand Name: VERSAFITCUP CC LINER
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734716
• Report Number: 3005180920-2018-00573
• Device Sequence Number: 1018277
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2023
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 179303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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