MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M

Model Number	01.29.202
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 2 years and 11 months, the patient came in reporting pain due to a subsided stem that was caused from an infection.The pathogen is unknown.The surgeon performed a washout and revised the stem, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 june 2025.Ball heads: mectacer 01.29.202 mectacer head biolox delta dia.28 12/14-m (k112115) lot.2118285 : (b)(4) items manufactured and released on 22/03/2022.Expiration date: 03/03/2027.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 components involved in the event: stem: quadra-p 01.12.124 quadra-p std stem size 4 (k181254) lot.2114267 : (b)(4) items manufactured and released on 09/02/2022.Expiration date: 27/01/2027.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.Liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø28/dmh ( k092265 ) lot.2115566: (b)(4) items manufactured and released on 12/01/2022.Expiration date: 19/12/2026.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.Clinical evaluation a revision surgery was performed approximately three years after the primary tha due to a late periprosthetic joint infection, which resulted in septic loosening and stem subsidence.Infection is a recognized potential adverse event following any surgical procedure, including tha.At present, there is no evidence to suggest a causal relationship between the infection and the implanted devices.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 DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M
• 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: 22518249
• Report Number: 3005180920-2025-00638
• Device Sequence Number: 12782244
• Product Code: LZO
• UDI-Device Identifier: 07630030809132
• UDI-Public: 07630030809132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 01.29.202
• Device Lot Number: 2118285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White