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

Model Number	01.29.201
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 november 2025.Ball heads: mectacer 01.29.201 mectacer head biolox delta dia.28 12/14-s (k112115) lot 2436086: (b)(4) items manufactured and released on 23-jan-2025.Expiration date: 26-dec-2029.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 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot 2428651: (b)(4) items manufactured and released on 30-dec-2024.Expiration date: 05-dec-2029.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.Cup: mpact 3d metal 01.38.056dh mpact 3d metal shell two hole d 56mm (k171966) lot 2109315: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 26-jul-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.Impact 01.32.4248cf dm converter f/dme - tin coated (k211891) lot.2310425: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 24-oct-2028.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.Other: screws 01.43.0025 cancellous bone screw d 6,5 l25 (k200391) lot.2319119: (b)(4) items manufactured and released on 13-sep-2023.Expiration date: 26-aug-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Other: screws 01.43.0025 cancellous bone screw d 6,5 l25 (k200391) lot.2428089: (b)(4) items manufactured and released on 17-dec-2024.Expiration date: 3-dec-2029.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
On (b)(6) 2025, the patient had primary left hip surgery.On (b)(6) 2025, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup, liner, and head.The surgery was completed successfully (mdr (b)(4)).On (b)(6) 2025, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the cup, screws, liner, dm converter and head.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23579953
• Report Number: 3005180920-2025-01141
• Device Sequence Number: 21208737
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (Y/N): N
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 01.29.201
• Device Lot Number: 2436086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White