Versacem Acetabular Shell and Double Mobility HC Liners 01.26.2846MHCRecalls & reported problems
Medacta International SA · Double Mobility HC Liner Ø28/DMC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630542703928), received between Mar 30, 2026 and Jul 6, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).
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 Rejection2
- Device Dislodged or Dislocated1
Patient problems
- Medical device site infection2
- Joint Dislocation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON REVISED THE MEDACTA CUP, LINER, DM CONVERTER AND HEAD TO COMPETITOR DEVICES.
Patient problems: Joint Dislocation
MAUDE report 25714727 ↗InjuryMay 5, 2026Device Appears to Trigger Rejection
THE PATIENT HAD INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 28/DMC LINER TO A SAME SIZE LINER AND REVISED THE 28MM BIOLOX HEAD L TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25077221 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 DAYS AFTER THE PRIMARY SURGERY DUE TO AN ACUTE JOINT INFECTION OF UNKNOWN ORIGIN.THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24711032 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- 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
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
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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