MAUDE Adverse Event Report: Medacta International SA Mectacer Biolox Delta Femoral Ball Head; MECTACER Head Biolox Delta dia.36 12/14-M

Model Number	01.29.209
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	08/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 days after the primary, the patient came in presenting pain due to dislocation of the head from the liner and the cause is unknown.The surgeon revised theflat pe hc linerd 36/eto a hooded pe hc liner d 36/e and themectacer head biolox delta d 36 12/14-mto a biolox head l.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 august 2026 ball heads: mectacer 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot 2614373: (b)(4) items manufactured and released on 10-jun-2026.Expiration date: 21-may-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 01.32.3644hct flat pe hc liner d 36/e (k103721) lot 2602343: (b)(4) items manufactured and released on 06-may-2026.Expiration date: 19-apr-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.Root cause: implant dislocation is possible literature described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: Mectacer Biolox Delta Femoral Ball Head
• Common Device Name: MECTACER Head Biolox Delta dia.36 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: 50692300
• Report Number: 3005180920-2026-00922
• Device Sequence Number: 9685017
• Product Code: LZO
• UDI-Device Identifier: 07630030809200
• UDI-Public: 07630030809200
• Combination Product (Y/N): N
• PMA/510(K) Number: K112115
• 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: 01.29.209
• Device Lot Number: 2614373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2026
• 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: 59 YR
• Patient Sex: Male