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

Model Number	01.29.232H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had signs of infection and the pathogen is unknown.At 2 years and 3 months post primary the surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 22 january 2025: lot 2109354: (b)(4) items manufactured and released on 12-nov-2021.Expiration date: 2026-10-07.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 implants revised: batch reviews performed on 22 january 2025 on liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot.2208326 lot 2208326: (b)(4) items manufactured and released on 15-jun-2022.Expiration date: 2027-05-30.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.Batch reviews performed on 22 january 2025 on cup: mpact 3d metal 01.38.062dh acetabular shell ø62 two-hole (k171966) lot.2011350 lot 2011350: (b)(4) items manufactured and released on 05-03-2021.Expiration date: 2026-02-22.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.Batch reviews performed on 22 january 2025 on stem: sms solid 01.36.053 sms solid stem std size 13 (k181693) lot.2009517 lot 2009517: (b)(4) items manufactured and released on 11-01-2021.Expiration date: 2025-12-21.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.Batch reviews performed on 22 january 2025 on other: screws 01.43.0030 cancellous bone screw ø 6,5 l 30 (k200391) lot.2208671 lot 2208671: (b)(4) items manufactured and released on 13-06-2022.Expiration date: 2027-05-18.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: MECTACER BIOLOX OPTION HEADS
• Common Device Name: HIP 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: 21320170
• Report Number: 3005180920-2025-00048
• Device Sequence Number: 15433296
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• 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: 2022
• Device Explanted Year: 2025
• 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): 02/06/2025

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 Model Number: 01.29.232H
• Device Lot Number: 2109354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2021
• 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: 58 YR
• Patient Sex: Male