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
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 ↗
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- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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