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	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary right hip surgery on (b)(6)2026.On (b)(6)2026, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the 28mm biolox delta head m to a 28mm biolox option head with option sleeve m, and revised the double mobility hc liner d 28/dmg to a same size liner.The surgery was completed successfully.Presently, the patient came in due to continued signs of infection and the pathogen is unknown.The surgeon revised all components (stem, head, liner, cup) to antibiotic spacers until the infection clears.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 august 2026 ball heads: mectacer 01.29.230h mectacer head biolox option 12/14 d 28 (k131518) lot 2606604: (b)(4)items manufactured and released on 07-apr-2026.Expiration date: 16-mar-2031.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 01.32.154mb mpact dm acetabular shell d 54 (k143453) lot 2518723: 60 items manufactured and released on 11-feb-2026.Expiration date: 02-feb-2031.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: mpact dm 01.26.2854mhc double mobility hc liner d 28/dmg (k092265) lot 2601012: (b)(4)items manufactured and released on 2-mar-2026.Expiration date: 11-feb-2031.No anomalies found related to the problem.To date, 64 items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem-p collared 01.18.444 amistem-p collared lat.Size 4 (k173794) lot 2300481: (b)(4) items manufactured and released on 2-may-2023.Expiration date: 5-apr-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.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.

• 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: 50692320
• Report Number: 3005180920-2026-00928
• Device Sequence Number: 9595743
• 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
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 2606604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2026
• 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: 67 YR
• Patient Sex: Female