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DM Converter – TiN coated 01.32.4248CFRecalls & reported problems

Medacta International SA · DM Converter F/DME - TiN coated · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971256361), received between Jul 1, 2024 and Jun 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1
  • Device Dislodged or Dislocated1

Patient problems

  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 24, 2026Device Dislodged or Dislocated

    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.

    Patient problems: Joint Dislocation

    MAUDE report 25607350 ↗
  • InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 1 MONTH AND 3 WEEKS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION. THE SURGEON REVISED SUCCESSFULLY THE IMPACT DM CONVERTER, DM LINER AND CERAMIC FEMORAL HEAD AND IMPLANTED A POLY HOODED LINER AND COCR FEMORAL HEAD.

    Patient problems: Unspecified Infection

    MAUDE report 19642081 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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