MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S

Model Number	01.29.204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month from the primary, the patient came in due to pain as the result of a dislocation of the head and liner and the cause is unknown.The surgeon revised the medacta cup and liner to a competitor cup and liner, and revised the medacta d 32mm biolox head s with a medacta cocr 12/14 d 28mm xxl head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09 jan 2026 ball heads: mectacer 01.29.204 mectacer head biolox delta dia.32 (k112115) lot 2520156: (b)(4)items manufactured and released on 29-aug-2025.Expiration date: 27-jul-2030.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 cc trio 01.26.3239 hct flat pe hc liner d 32/c (k120531) lot 2517078: (b)(4) items manufactured and released on 29-aug-2025.Expiration date: 28-jul-2030.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.Clinical evaluation few days after primary cementless tha dislocation occurs, and the surgeon replaces head and acetabular components.The original head used was "short" the revision head is extra_extra-long, suggesting that the primary tension may not have been sufficient to hold the head in place.The a-p intraoperative fluoroscopy shot shoes a rather peculiar view where the head seems to have not fully entered the cup, as if it was too large in diameter, but this may be an artifact due to the intraoperative image - the joint may not have been properly reduced yet, when the image was taken.The stem did not subside.The cause for this adverse event is not to be attributed to a defective device.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-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: 24162755
• Report Number: 3005180920-2026-00044
• Device Sequence Number: 9252145
• Product Code: LZO
• UDI-Device Identifier: 07630030809156
• UDI-Public: 07630030809156
• 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: 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): 01/23/2026

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: 01.29.204
• Device Lot Number: 2520156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White