MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 48

Model Number	01.26.48MB
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 november 2020: lot 178346: (b)(4) items manufactured and released on 14-mar-2018.Expiration date: 2023-03-04.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Other device involved in the event: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 lot.176358 (k112115).Batch review performed on 16 november 2020: lot 176358: (b)(4) items manufactured and released on 08-mar-2018.Expiration date: 2023-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
There was a joint geometry issue.Malalignment of the cup and leg length was a bit short.Cup needed to be revised to correct the joint geometry.Cup, liner and head were revised successfully 1 year and 8 months after primary.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10928295
• Report Number: 3005180920-2020-00859
• Device Sequence Number: 791292
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 178346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/01/2020
• 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
• Patient Age: 52 YR