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

Model Number	01.32.4248CF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of the surgery, after wound closure, while the patient was still under anesthesia, a joint dislocation involving the head and liner of the double mobility converter occurred during repositioning from the lateral to the supine position.Stability tests had been performed before moving the patient and did not show any dislocation.The surgeon therefore immediately decided to replace the components in order to address the dislocation.However, no compatible insert was available in stock to combine a new head with a new liner.Therefore, the surgery was completed using a bigger competitor`s head and liner, while leaving the medacta double mobility converter and cup in place.The surgery was prolonged by approximately 30 minutes due to the event.
Additional Manufacturer Narrative
Batch review performed on 29 may 2026 liner: mpact dm 01.32.4248cf dm converter f/dme - tin coated (k211891) lot 2534278: (b)(4) items manufactured and released on 14-apr-2026.Expiration date: 31-mar-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 dm 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot 2601006: (b)(4) items manufactured and released on 10-mar-2026.Expiration date: 17-feb-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: based on the information available, the reported dislocation is considered a peri-operative complication that occurred immediately after surgery, during patient repositioning.Although intra-operative stability tests had been performed with satisfactory outcome before moving the patient, the event may have been related to case-specific surgical and/or biomechanical factors, including the selected implant configuration.The issue was immediately addressed by revising the head and liner and using a larger head size to restore joint stability.No definitive device-related root cause can be established based on the available information.

• Brand Name: DM CONVERTER ¿ TIN COATED
• Common Device Name: DM CONVERTER F/DME - 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: 25607350
• Report Number: 3005180920-2026-00586
• Device Sequence Number: 5405864
• Product Code: LZO
• UDI-Device Identifier: 07630971256361
• UDI-Public: 07630971256361
• Combination Product (Y/N): N
• PMA/510(K) Number: K211891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/24/2026

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: 01.32.4248CF
• Device Lot Number: 2534278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2026
• 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 Sex: Unknown