MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28; HIP FEMORAL HEAD

Catalog Number	01.29.230H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(3) 2023.Lot 2315673: 10 items manufactured and released on 06-jul-2023.Expiration date: 2028-06-14.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported case during the period of review.Additional components involved: batch review performed on (b)(3) 2023.Liner: mpact dm 01.26.2856mhc double mobility hc liner 28/dmh (k092265) lot 2302834: 60 items manufactured and released on 12-apr-2023.Expiration date: 2028-03-27.No anomalies found related to the problem.To date, 38 items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot 2308486: 10 items manufactured and released on 14-jun-2023.Expiration date: 2028-05-23.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the head, liner and option sleeve.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
• Common Device Name: 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: 18334851
• Report Number: 3005180920-2023-01024
• Device Sequence Number: 8407002
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.29.230H
• Device Lot Number: 2315673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male