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

Model Number	01.26.48MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 march 2021: lot 153606: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.Another devices involved: batch review performed on 01 march 2021: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115).Lot.154923: (b)(4) items manufactured and released on 09-dec-2015.Expiration date: 2020-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.Batch review performed on 01 march 2021: liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265)lot.152688: (b)(4) items manufactured and released on 08-sep-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.
Event or Problem Description
The patient came in reporting pain 4 years 11 months after the primary and the cause of the pain is unknown.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• 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: 11398506
• Report Number: 3005180920-2021-00154
• Device Sequence Number: 4568261
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 08/31/2020
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 153606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 03/02/2021
• 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