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

Model Number	01.26.48MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 2 febbraio 2021: lot 091607: (b)(4) items manufactured and released on 21-aug-2009.Expiration date: 2014-06-30.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 since 2017.Additional device involved: batch review performed by medacta regulatory affairs department on 2 febbraio 2021: liner: versafitcup dm 01.26.2848m double mobility liner ø 48/28 (k083116) lot 092004: (b)(4) items manufactured and released on 14-sep-2009.Expiration date: 2014-07-31.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 since 2017.
Event or Problem Description
The patient came in 10 years and 11 months after the primary surgery reporting pain and the cause of the pain is unknown.The surgeon revised the competitor stem with a competitor stem, the medacta cup with a competitor cup, and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL 48
• Common Device Name: HIP CEMENTLESS CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11331088
• Report Number: 3005180920-2021-00129
• Device Sequence Number: 823293
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: 06/30/2014
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 091607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/16/2021
• 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