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

Catalog Number	01.26.50MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9510720
• Report Number: 3005180920-2019-01106
• Device Sequence Number: 16836536
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 08/17/2024
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 1902300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• 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