MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEADS; 316LVM BIPOLAR HEAD Ø28 X 46

Model Number	25060.2846
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 months from the primary,the patient presented with pain due to a dislocation of the bi-polar head from the femoral head following a fall.The surgeon revised the bi-polar head with another one of the same size.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 may 2026 ball heads: bipolar head 25060.2846 316lvm bipolar head d 28 x 46 (k091967) lot 2417181: (b)(4) items manufactured and released on 21-nov-2024.Expiration date: 29-oct-2029.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.Ball heads: cocr 01.25.012 cocr ball head 12/14 d 28 mm size m (k072857) lot 2417946: (b)(4) items manufactured and released on 11-dec-2024.Expiration date: 20-nov-2029.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:the issue may have related to the specific parameters of the initial surgery, but this cannot be confirmed.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: BIPOLAR HEADS
• Common Device Name: 316LVM BIPOLAR HEAD Ø28 X 46
• 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: 25268618
• Report Number: 3005180920-2026-00493
• Device Sequence Number: 9185535
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (Y/N): N
• PMA/510(K) Number: K091967
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 25060.2846
• Device Lot Number: 2417181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2024
• 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 Sex: Female
• Patient Race: White