Double Mobility Liner 01.26.2850MRecalls & reported problems
Medacta International SA · PE Liner 28 / DME · Class 2 · Implant
Data updated Oct 13, 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 07630030807275), received between Dec 7, 2017 and Dec 23, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K083116); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Naturally Worn2
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information1
- Joint Disorder1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2021Naturally Worn
THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON DECIDED TO REVISE THE PATIENT FOLLOWING SUSPECTED LINER WEAR. THE SURGEON REVISED THE COMPETITOR'S HEAD AND MEDACTA POLY 12 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 13078037 ↗InjuryJan 4, 2019Naturally Worn
DURING A CONSULTATION THE SURGEON DETECTED LINER WEAR. THE REVISION IS NOT SCHEDULED YET. MORE INFO WILL FOLLOW THE CASE.
Patient problems: No Code Available
MAUDE report 8217184 ↗InjuryDec 7, 2017Patient-Device Incompatibility
EIGHT YEARS AFTER PRIMARY THE PATIENT COMPLAINED LEG LENGTH DISCREPANCY. THE SURGEON DETECTED OSTEOSIS DUE TO THE LENGTH DISCREPANCY. THE SURGEON SWAPPED SUCCESSFULLY THE PATIENT HEAD AND LINER.
Patient problems: Joint Disorder
MAUDE report 7095378 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083116. One submission often covers many models, so check the product and lot details in each record.
- Z-2709-2011 · May 23, 2011 · TerminatedProduct Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is
- Z-0878-2013 · Jan 15, 2010 · TerminatedVersafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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