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 Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain due to joint luxation; the head came off the liner, and the cause is unknown.There was no indication of trauma or fall.At about 1 month and a half post-primary.The surgeon revised the two-hole acetabular shell to an mpact dm acetabular shell d 50, revised the 32mm biolox head s to a 28mm biolox head l, and revised the flat pe hc liner d 32/d to a double mobility hc liner d 28/dme.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 31 august 2026: ball heads: mectacer 01.29.204 mectacer head biolox delta dia.32 12/14-s (k112115) lot 2529444: (b)(4) items manufactured and released on 28-nov-2025.Expiration date: 16-nov-2030.No anomalies were 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 01.32.3241hct flat pe hc liner d 32/d (k103721) lot 2530220: (b)(4) items manufactured and released on 17-dec-2025.Expiration date: 26-nov-2030.No anomalies were 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: based on the information available, no definitive root cause can be established.No trauma or fall was reported, and the batch review did not identify any potentially related manufacturing issue.There is no indication that a potential device-related issue may have caused or contributed to the event.

• 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: 50692309
• Report Number: 3005180920-2026-00927
• Device Sequence Number: 21231257
• 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: 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: 01.29.204
• Device Lot Number: 2529444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2025
• 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: 71 YR
• Patient Sex: Female