MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX OPTION HEADS; MECTACER HEAD BIOLOX OPTION 12/14 Ø 28

Model Number	01.29.230H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 may 2026 stem: m-vizion 01.22.427 proximal body d 24mm l 40mm lat with holes (k201471) lot: 2407737: (b)(4) items manufactured and released on 25-sep-2024.Expiration date: 2029-09-09.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.Ball heads: mectacer 01.29.243a mectacer sleeve 12/14 size xl (k131518) lot: 2527384: (b)(4) items manufactured and released on 05-nov-2025.Expiration date: 2030-10-20.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.Ball heads: mectacer 01.29.230h mectacer head biolox option 12/14 d 28 (k131518) lot: 2410989: (b)(4) items manufactured and released on 02-may-2024.Expiration date: 2029-04-16.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.Stem: m-vizion 01.22.103 distal stem d 14mm l 140mm straight (k170690) lot: 2318726: (b)(4) items manufactured and released on 29-jan-2024.Expiration date: 2029-01-10.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.Root cause: 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
Primary surgery (date unknown) the patient initially underwent primary hip arthroplasty with competitor implants.On (b)(6) 2024, the patient presented with signs of infection (unknown pathogen).All components were removed and antibiotic spacers were implanted.Surgery was completed successfully.On (b)(6) 2024, the patient underwent revision surgery with replacement of antibiotic spacers.On (b)(6) 2024, the spacers were removed with implantation of a medacta distal stem and proximal body.On (b)(6) 2024 (mdr: (b)(4), the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the proximal body.On (b)(6) 2025 (mdr: (b)(4), the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the proximal body.On (b)(6) 2026, the patient came in due to an acute infection.The surgeon performed wash-out and implanted a permanent medacta head with sleeve and revised the proximal body.On (b)(6) 2026, the patient came in due to chronic infection, all medacta and competitor components were removed and antibiotic spacers were implanted.Surgery was completed successfully.On (b)(6) 2026, the patient presented with pain due to dislocation of the head from the liner while sleeping, without trauma.The head and liner (antibiotic spacer) were revised.Surgery was completed successfully.

• Brand Name: MECTACER BIOLOX OPTION HEADS
• Common Device Name: MECTACER HEAD BIOLOX OPTION 12/14 Ø 28
• 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: 25123172
• Report Number: 3005180920-2026-00390
• Device Sequence Number: 10646444
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/08/2026

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: 01.29.230H
• Device Lot Number: 2410989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2024
• 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: 61 YR
• Patient Sex: Female