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

Catalog Number 01.29.205

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/28/2024

Event Type  Injury  

Event Description

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

Manufacturer Narrative

Batch review performed on 02-apr-2024.Lot 2339371: (b)(4) items manufactured and released on 26-oct-2023.Expiration date: 2028-10-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 02-apr-2024: liner: mpact 01.32.3244hct flat pe hc liner ø32/e (k103721) lot 2304467: (b)(4) items manufactured and released on 06-apr-2023.Expiration date: 2028-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
• Type of Device: HIP 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: 19178637
• MDR Text Key: 341001242
• Report Number: 3005180920-2024-00249
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• 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: 04/25/2024

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: 01.29.205
• Device Lot Number: 2339371
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2023
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Race: White