MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M

Model Number	01.29.209
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta clinical affairs manager: a revision surgery was performed approximately one year after the implantation of a tha.The reported reason for the revision was inadequate osseointegration secondary to a chronic infection.This diagnosis was made by the surgeon based on scintigraphic findings.The available x-ray images confirm prosthetic loosening, particularly on the femoral stem side, evidenced by radiolucent lines and signs of bone remodeling.Late periprosthetic infection is a well-documented potential complication following surgery and is described and quantified in the scientific literature.Based on the information currently available, there is no indication that the failure is related to a defect or malfunction of the implanted devices.Batch review performed on 29 july 2025: ball heads: mectacer 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot.2403638: (b)(4) items manufactured and released on 27 feb 2024.Expiration date: 11-feb-2029.No anomalies were 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.Cup: versafitcup cc 01.26.45.0050 versafutcup cc trio (k103352) lot.2344673: (b)(4) items manufactured and released on 09 jan 2024.Expiration date: 16-dec-2028.No anomalies were found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem p 01.18.403 amistem-p std.Size 3 (k173794) lot.2346809: (b)(4) items manufactured and released on 21 march 2024.Expiration date: 04-mar-2029.No anomalies were 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.Not registered in the usa liner: versafitcup cc trio 01.29.413 ceramic liner e head 36 lot.2346031: (b)(4) items manufactured and released on 21 dec 2023.Expiration date: 04-dec-2028.No anomalies were found related to the problem.To date, all 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.
Event or Problem Description
At about 1 year and 2 months after the primary surgery, the patient presented with healing issues.A scintigraphy revealed a defect in the osseointegration of the femoral pivot.The surgeon decided to replace the prosthesis, considering the case to be a chronic infection, confirmed by the samples.
Additional Manufacturer Narrative
Visual inspection performed by r&d department/ visual inspection performed on 26 august 2025.The shell appeared without any visible defect that could be related to the event.Some fibrotic tissue was present on the dome and on the macrostructures, probably indicating good osseointegration.The liner and head were intact, without any sign of damage, but only few signs of usage and related to implant removal; finally, a good articulation remains between the two components.From the visual inspection, it is not possible to determine the route cause of the event.Updated fields: h11.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER MECTACER HEAD BIOLOX DELTA DIA.36 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: 22737159
• Report Number: 3005180920-2025-00767
• Device Sequence Number: 15258436
• Product Code: LZO
• UDI-Device Identifier: 07630030809200
• UDI-Public: 07630030809200
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 09/04/2025

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: 01.29.209
• Device Lot Number: 2403638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White