MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M; HIP DELTA CERAMIC BALL HEAD

Catalog Number 01.29.209

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/07/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 november 2023: lot 1907359: (b)(4) manufactured and released on 08-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Other components involved: liner: mpact 01.32.3641hc4 offset 4mm pe hc liner ø36/d (k183582) lot 1810834: (b)(4) manufactured and released on 04-mar-2019.Expiration date: 2024-02-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with other 2 similar reported events in the period of review.

Event Description

Revision due to hip luxation and the cause is unknown.At about 1 year and a half post primary surgery the surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
• Type of Device: HIP DELTA CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18272865
• MDR Text Key: 329774716
• Report Number: 3005180920-2023-00940
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112115
• 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: 12/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.29.209
• Device Lot Number: 1907359
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2020
• 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