MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 54; ACETABULAR CUP

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 february 2018: lot 164503: 90 items manufactured and released on 26 october 2016.Expiration date: 2021-10-13.No anomalies found related to the issue.To date, 64 items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5 reference (b)(4).Lot 167712: 90 items manufactured and released on 13 march 2017.Expiration date: 2020-06-30.No anomalies found related to the issue.To date, 71 items of the same lot have been already sold without any similar reported event.Double mobility hc liner ø 54/28 reference (b)(4).Lot 165710: 55 items manufactured and released on 21 november 2016.Expiration date: 2021-10-26.No anomalies found related to the issue.To date, 44 items of the same lot have been already sold without any similar reported event.Amistem h ha coated std stem size 3 reference (b)(4).Lot 170013: 114 items manufactured and released on 15 may 2017.Expiration date: 2022-05-23.No anomalies found related to the issue.To date, 94 items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The patient had a primary hip on (b)(6) 2017.The patient came in complaining of instability.The cause was unknown.During revision, the surgeon determined the patient was infected.The pathogen is unknown.The surgeon removed all medacta hardware and implanted a spacer.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276204
• Report Number: 3005180920-2018-00049
• Device Sequence Number: 11338029
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 10/13/2021
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 164503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/16/2018
• 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