MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X49 HIP BIPOLAR HEAD

Model Number 25060.2849

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/20/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23 feb 2022: lot 180449: 34 items manufactured and released on 13-jun-2018. Expiration date: 2023-may-28. No anomalies found related to the problem. To date, 25 items of the same lot have been sold with no similar reported event. Additional device involved: batch review performed on 23 feb 2022: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2111102: 200 items manufactured and released on 24-noc-2021. Expiration date: 2026-nov-11 no anomalies found related to the problem. To date, 109 items of the same lot have been sold with no similar reported event.

Event Description

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

• Brand Name: BIPOLAR HEAD Ø28X49
• Type of Device: HIP BIPOLAR HEAD
• 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: 13802614
• MDR Text Key: 287430026
• Report Number: 3005180920-2022-00191
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091967
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 25060.2849
• Device Catalogue Number: 25060.2849
• Device Lot Number: 180449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2018
• 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: 03/17/2022 Patient Sequence Number: 1