Double Mobility LinerRecalls & reported problems across all models
Medacta International SA · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 260
- Deaths reported
- 0
- Injuries reported
- 257
- Recalls
- 0
We found 20 models of Double Mobility Liner by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 260 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2017 and Jun 30, 2026 — classified as 257 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (51 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Double Mobility Liner problems
Device problems
- Appropriate Device Problem Term/Code Not Available87
- Adverse Event Without Identified Device or Use Problem53
- Device Appears to Trigger Rejection51
- Device Dislodged or Dislocated26
- Naturally Worn9
- Insufficient Device Problem Information7
- Inadequacy of Device Shape and/or Size5
- Loose or Intermittent Connection4
Patient problems
- Unspecified Infection104
- Medical device site infection40
- Pain32
- Joint Dislocation21
- Joint Disorder12
- Implant Pain10
- Osteolysis9
- Unequal Limb Length8
Double Mobility Liner models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Double Mobility Liner 01.26.2850MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate54 reports
- Double Mobility Liner 01.26.2848MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate48 reports
- Double Mobility Liner 01.26.2852MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate35 reports
- Double Mobility Liner 01.26.2856MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate31 reports
- Double Mobility Liner 01.26.2854MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate25 reports
- Double Mobility Liner 01.26.2858MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate15 reports
- Double Mobility Liner 01.26.2246MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate8 reports
- Double Mobility Liner 01.26.2848MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate8 reports
- Double Mobility Liner 01.26.2860MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate7 reports
- Double Mobility Liner 01.26.2852MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate6 reports
- Double Mobility Liner 01.26.2856MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Double Mobility Liner 01.26.2244MHCProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Double Mobility Liner 01.26.2850MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Double Mobility Liner 01.26.2854MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Double Mobility Liner 01.26.2858MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Double Mobility Liner 01.26.2862MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Double Mobility Liner 01.26.2242MHCProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Double Mobility Liner 01.26.2246MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Double Mobility Liner 01.26.2860MProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Double Mobility Liner 01.26.2864MHCProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
Recent Double Mobility Liner adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Device Dislodged or Dislocated
THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER. THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE 28 MM BIOLOX DELTA HEAD L TO A COCR BALL HEAD 12/14 D 28 MM SIZE XL AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD AN MPACT MH WITH DM CONVERTER ON (B)(6) 2026 IN A REVISION OF COMPETITOR DEVICES.
Patient problems: Joint Dislocation
MAUDE report 25663304 ↗InjuryJun 26, 2026Device Appears to Trigger Rejection
AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD AND REVISED THE D 28/DMI HC LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25632994 ↗InjuryMay 25, 2026Device Appears to Trigger Rejection
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DMD TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25268624 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY AFTER 1 MONTH FROM THE PRIMARY DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER TO A SAME SIZE LINER, AND REVISED THE HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25160343 ↗MalfunctionMay 12, 2026Device Dislodged or Dislocated
THE PATIENT UNDERWENT PRIMARY LEFT HIP SURGERY WITH A CUSTOM ACETABULAR CUP ON (B)(6) 2026, UNDER COMPASSIONATE USE. APPROXIMATELY THREE WEEKS LATER, THE PATIENT EXPERIENCED A DISLOCATION OF THE LINER FROM THE HEAD AFTER A TWISTING MOVEMENT. THE DISLOCATION WAS MANUALLY REDUCED WITHOUT THE USE OF ANESTHESIA.
Patient problems: Joint Dislocation
MAUDE report 25148978 ↗InjuryMay 12, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2026, THE PATIENT HAD A MEDACTA D 28/DMF LINER AND D 52 MM VERSACEM METALBACK CUP IMPLANTED. ON (B)(6) 2026, THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER TO A SAME SIZE LINER AND REVISED THE D 52 CUP TO A D 56 MM CUP AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25148953 ↗InjuryMar 31, 2026Naturally Worn
AT16 YEARS 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A WORN LINER. THE SURGEON REVISED THE D 28 HEAD TO A 28MM BIOLOX OPTION HEAD WITH A MEDIUM SLEEVE, AND REVISED THE 60MM X 28 VERSAFIT LINER FOR A D 28 DOUBLE MOBILITY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 24741264 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION ABOUT 2 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 28 MM BIOLOX HEAD TO A SAME SIZE HEAD AND REVISED THE D 28 DOUBLE MOBILITY LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24711257 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
AT 1 YEAR 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE D 28 DOUBLE MOBILITY LINER TO A LINER OF THE SAME SIZE AND REVISED THE 28MM BIOLOX HEAD TO A HEAD OF THE SAME SIZE WITH A BIOLOX OPTION SLEEVE L. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 24588556 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PERFORMED ONE MONTH AFTER THE PRIMARY PROCEDURE DUE TO INFECTION OF UNKNOWN CAUSE. THE SURGEON PERFORMED A WASHOUT AND REPLACED THE LINER WITH THE SAME SIZE, AS WELL AS THE FEMORAL HEAD WITH THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24482262 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD SIGNIFICANT LEG DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED HEAD AND LINER AT ABOUT 16 YEARS AFTER PRIMARY AND CHECKED THE STEM AND CUP TO ENSURE THEY WERE STABLE AND HAD NOT BECOME LOOSE. IT IS UNCLEAR WHAT MAY HAVE CONTRIBUTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unequal Limb Length
MAUDE report 24454888 ↗InjuryFeb 12, 2026Device Appears to Trigger Rejection
AT 6 YEARS 1 MONTH FROM PRIMARY,THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER WITH A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24321120 ↗InjuryJan 14, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN FOR DUE TO A SUBSIDED COMPETITOR STEM. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND REVISED THE COMPETITOR HEAD AND STEM TO A DIFFERENT COMPETITOR HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR STEM AND HEAD WITH A NEW COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A NEW MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24068441 ↗InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23837351 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD REVISION SURGERY OF MEDACTA PRODUCT BUT THE PRIMARY TICKET FOR THE PATIENT CANNOT BE LOCATED. THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON, ACCORDING TO THE COMPLAINT, REVISED A D 48 DM LINER AND 28MM M HEAD TO THE SAME SIZE MEDACTA LINER AND HEAD WITH A SLEEVE TO IMPROVE PATIENT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 23837347 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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