MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC FLAT PE HC LINER Ø 36 / F; FLAT LINER

Catalog Number	01.26.3648HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018.Lot 134671: (b)(4) items manufactured and released on 03 december 2013.Expiration date: 2018-10-31.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.Other device involved: mectacer reference 01.29.209 (k112115) biolox delta ceramic ball head 12/14 ø 36 size m 0.Lot 174039: (b)(4) items manufactured and released on 20 october 2017.Expiration date: 2022-09-24.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.
Event or Problem Description
Revision surgery performed due to infection after about 1 month from the primary.The pathogen is not known.Head and inlay were revised.

• Brand Name: VERSAFITCUP CC FLAT PE HC LINER Ø 36 / F
• Common Device Name: FLAT LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7909562
• Report Number: 3005180920-2018-00730
• Device Sequence Number: 13883740
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 10/31/2018
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 134671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial 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: Required Intervention