MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28

Model Number 01.26.2848MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 october 2020 lot 1909376: (b)(4) items manufactured and released on 29jann-2020. Expiration date: 2025-01-13. No anomalies found related to the problem. To date, 73 items of the same lot have been already sold with another similar reported event. Other device involved in the event: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot. 1909750 (k112115). Batch review performed on 07 october 2020: lot 1909750: (b)(4) items manufactured and released on 03-mar-2020. Expiration date: 2025-02-17. No anomalies found related to the problem. To date, 185 items of the same lot have been already sold without any similar reported event.

Event Description

Revision surgery 21 days after primary for hip infection. The surgeon performed a washout and revised the head and liner. The surgery was completed successfully. The pathogen is unknown.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28
• Type of Device: DOUBLE MOBILITY HC 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: 10697604
• MDR Text Key: 211901470
• Report Number: 3005180920-2020-00739
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): Y
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 1909376
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• 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: 10/19/2020 Patient Sequence Number: 1