MAUDE Adverse Event Report: Medacta International SA Mectacer Biolox Delta Femoral Ball Head; MECTACER Head Biolox Delta dia.32 12/14-M

Model Number	01.29.205
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent primary hip surgery on (b)(6) 2024.Prior to the primary surgery, the patient had sustained a pelvic fracture, which had already healed.Two years and four months after the primary surgery, the patient experienced an anterior dislocation.An open revision was considered but was ultimately deemed unnecessary, as the surgeon successfully performed a closed reduction.No implant components were exchanged.To date, no further dislocation or other related event has been reported.
Additional Manufacturer Narrative
Batch review performed on 12 aug 2026 ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot 2338625: (b)(4) items manufactured and released on 11-oct-2023.Expiration date: 2028-sept-25.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.Liner: mpact 01.32.3239hct flat pe hc liner d 32/c (k103721) lot.2309697: (b)(4) items manufactured and released on 13-jun-2023.Expiration date: 2028-may-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported events 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.

• Brand Name: Mectacer Biolox Delta Femoral Ball Head
• Common Device Name: MECTACER Head Biolox Delta dia.32 12/14-M
• 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: 50692267
• Report Number: 3005180920-2026-00888
• Device Sequence Number: 5927838
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (Y/N): N
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 01.29.205
• Device Lot Number: 2338625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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: Other
• Patient Sex: Unknown