MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50; ACETABULAR CUP

Catalog Number 01.26.50MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 december 2019: lot 1902300: (b)(4) items manufactured and released on 27-ago-2019.Expiration date: 2024-08-17.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 involved: liner: versafitcup dm 01.26.2850mhc double mobility hc liner 50/28 (k092265) lot.1904369.Batch review performed on 16 december 2019: lot 1904369: (b)(4) items manufactured and released on 05-sept-2019.Expiration date: 2024-08-25.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 involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot.1903847 batch review performed on 16 december 2019: lot 1903847: 210 items manufactured and released on 26-jul-2019.Expiration date: 2024-07-13.No anomalies found related to the problem.To date, 118 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in due to signs of an infection and the pathogen is unknown.About 2 weeks after primary the surgeon performed a washout and revised the head, liner, and cup and the surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 50
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9510720
• MDR Text Key: 188115788
• Report Number: 3005180920-2019-01106
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 1902300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention