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

Catalog Number	01.26.56MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 july 2019: lot 172683: (b)(4) items manufactured and released on 03.Nov.2017.Expiration date: 2022-oct-23.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.Additional implant: liner: versafitcup dm 01.26.2856mhc versafitcup dm liner hc 56/28 (k092265) lot.187123.Batch review performed on 22 july 2019: lot 187123: (b)(4) items manufactured and released on 13.Nov.2018.Expiration date: 2023-oct-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.
Event or Problem Description
Second revision surgery performed after 3 months from the first revision due to an infection(the pathogen is unknown).The cup and the liner have been revised successfully.The first revision surgery has been performed after 4 months from the primary also due to an infection.(pathogen unknown).The surgeon performed the washout and revised another company's head and liner with medacta products.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC Ø 56
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8841175
• Report Number: 3005180920-2019-00654
• Device Sequence Number: 13524397
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 10/23/2022
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 172683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/30/2019
• 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