MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 56; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.56MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 april 2019: lot 114528: (b)(4) items manufactured and released on 03-mar-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Additional implant involved: stem: amistem h 01.18.132 ha coated std stem size 2 (k093944), lot 120133: (b)(4) items manufactured and released on 27-mar-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 6 years after primary revision surgery for cup/stem impingement.The surgeon revised the patient cup, stem, liner and ceramic head.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 56
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8514352
• Report Number: 3005180920-2019-00276
• Device Sequence Number: 1899718
• Product Code: MEH
• UDI-Device Identifier: 07630030808173
• UDI-Public: 07630030808173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 01/31/2017
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 114528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/15/2019
• 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