MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DM CONVERTER ¿ TIN COATED; DM CONVERTER E/DMC - TIN COATED

Model Number	01.32.3844CF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 march 2026.Liner: mpact dm 01.26.2846mhc double mobility hc liner d 28/dmc (k241767) lot 2510833: (b)(4) items manufactured and released on 30-jul-2025.Expiration date: 02-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: mpact dm 01.32.3844cf dm converter e/dmc - tin coated (k211891) lot 2308607: (b)(4) items manufactured and released on 13-sep-2023.Expiration date: 22-aug-2028.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:dislocation is a 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.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
The patient had primary surgery on (b)(6) 2020.On (b)(6) 2026, the patient came in due to a dislocation of the head and liner as the result of a fall.The surgeon revised the 36mm head and d 36 liner to a 28mm head and d 28 liner.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in presenting pain due to a dislocation of the dm liner and dm converter.The cause is unknown as no trauma was reported.The surgeon revised the dm biolox d 28 liner to a face chang 10° pe hd liner d 36 and revised the 28mm biolox delta head m to a 36mm biolox delta head xl.The surgery was completed successfully.

• Brand Name: DM CONVERTER ¿ TIN COATED
• Common Device Name: DM CONVERTER E/DMC - TIN COATED
• 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: 24738822
• Report Number: 3005180920-2026-00272
• Device Sequence Number: 9835325
• Product Code: LZO
• UDI-Device Identifier: 07630971256354
• UDI-Public: 07630971256354
• Combination Product (Y/N): N
• PMA/510(K) Number: K211891
• 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): 03/31/2026

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: 01.32.3844CF
• Device Lot Number: 2308607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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: Required Intervention
• Patient Sex: Unknown