MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M; HIP FEMORAL HEAD

Model Number 01.29.205

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During total hip replacement surgery on (b)(6) 2021, wrong size of the head, ø32 instead of ø36 has been implanted (liner g must be used with head ø36).The patient underwent to a revision surgery to replace that component.The revision surgery date is unknown.

Manufacturer Narrative

Batch review performed on 17 march 2023.Lot 2011664: (b)(4) items manufactured and released on 23-march-2021.Expiration date: 2026-02-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Note: the field "date of the event" is empty because we don't know when the use error was discovered and when the patient underwent to a revision surgery.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
• Type of Device: HIP FEMORAL 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: 16741093
• MDR Text Key: 313293476
• Report Number: 3005180920-2023-00229
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.29.205
• Device Catalogue Number: 01.29.205
• Device Lot Number: 2011664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2021
• 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
• Patient Sex: Male