MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 HIP SHELL LINER

Model Number 01.26.2850MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 april 2021: lot 2006366: (b)(4) items manufactured and released on 3-aug-2020. Expiration date: 2025-07-21. 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 devices involved: batch reviews performed on 30 april 2021: cup: mpact 01. 32. 150mb double mobility acetabular shell ¿50 (k143453) lot 2006087: (b)(4) items manufactured and released on 21-oct-2020. Expiration date: 2025-10-12. 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. Stem: quadra-p 01. 12. 121 quadra-p std stem size 1 (k181254) lot 2002666: (b)(4) items manufactured and released on 30-jun-2020. Expiration date: 2025-07-20. 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. Ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ¿ 28 size m 0 (k112115) lot 2006678: (b)(4) items manufactured and released on 5-oct-2020. Expiration date: 2025-09-24. 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 Description

1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is staphylococcus aureus. The surgeon performed a washout and revised all implants. The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
• Type of Device: HIP SHELL LINER
• 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: 11831972
• MDR Text Key: 250866236
• Report Number: 3005180920-2021-00387
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2006366
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/17/2021 Patient Sequence Number: 1