Double Mobility Liner 01.26.2244MHCRecalls & reported problems
Medacta International SA · HC PE Liner 22 / DMB · Class 2 · Implant
All models of Double Mobility Liner (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030806803), received between Apr 20, 2018 and Nov 10, 2023 — classified as 4 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
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Infection3
- Dizziness1
- Fall1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT THE PATIENT SUSTAINED WHILE DANCING. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, 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: Unspecified Infection
MAUDE report 18111194 ↗InjuryFeb 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME PRESENTING INFLAMED TISSUES DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.
Patient problems: Unspecified Infection
MAUDE report 16427658 ↗InjuryMar 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO INTRA-PROSTHETIC DISLOCATION BETWEEN THE COCR HEAD AND THE HIGH CROSS DOUBLE MOBILITY LINER. PREVIOUSLY THE PATIENT FELL AFTER A DIZZY SPELL IN (B)(6) 2020 AND INCURRED A PELVIC FRACTURE. A CLOSE REDUCTION OF THE HIP WAS PERFORMED AT THAT MOMENT. AFTER THE REVISION SURGERY, THE HEAD WAS COUPLED WITH THE LINER AGAIN AND TRIED TO REMOVE IT BY HAND, BUT IT WAS NOT POSSIBLE. THE IMPLANTS WERE THOROUGHLY WASHED AND LEFT IN ALCOHOL FOR AN HOUR SINCE STERILIZATION WAS NOT POSSIBLE TO BE PERFORMED.
Patient problems: Dizziness; Fall
MAUDE report 11503405 ↗InjuryApr 20, 2018Appropriate Device Problem Term/Code Not Available
THREE DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION IMPLANTING A SPACER MADE BY: MASTERLOC STEM, COCR HEAD, CEMENTING MPACT LINER AND USING A COMPETITOR SPACER FOR THE ACETABULUM. ON THE (B)(6) 2018 THE SURGEON SWAPPED THE SPACED WITH DEFINITIVE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY
Patient problems: Unspecified Infection
MAUDE report 7446814 ↗
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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