MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8

Model Number	01.29.215
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to joint luxation, at about 3 years 10 months from the primary.The surgeon revised the head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 november 2023.Lot 1904653: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional involved implant: batch review performed on 06 november 2023 on liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot.1900223.Lot 1900223: (b)(4) items manufactured and released on 16-apr-2019.Expiration date: 2024-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.
Additional Manufacturer Narrative
Previous mdr sent: 2022-00637.2022-00696.2023-00238.2023-00737.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.Subsequently, the head dislocated from the liner.On (b)(6) 2022, the surgeon revised the head and liner.Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2022, the surgeon performed a washout and revised the head and liner.Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2023, the surgeon performed a washout, revised all implants.Subsequently, the patient came in sue to signs of infection and the pathogen was unknown.On (b)(6) 2023, the surgeon performed a washout, revised all implants.Presently, the patient came in due to a dislocation of the head from the liner.On (b)(6)2023, the surgeon revised the head and liner and implanted a dm converter.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Ball heads: mectacer 01.29.215 biolox delta ceramic ball head 12/14 ø 40 size xl +8 (k112115) lot 2218785: (b)(4) items manufactured and released on 02-nov-2022.Expiration date: 2027-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot 2215506: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review correction: d1.D2.D4.G4.H4.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8
• 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: 18191308
• Report Number: 3005180920-2023-00918
• Device Sequence Number: 7237913
• Product Code: LZO
• UDI-Device Identifier: 07630030809262
• UDI-Public: 07630030809262
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2025

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: 01.29.215
• Device Catalogue Number: 01.29.210
• Device Lot Number: 2218785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023; Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/21/2023; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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