DJO SURGICAL 428-00-100Recalls & reported problems
Encore Medical, L.P. · LIMA MODULAR REVISION HIP Revision Body, Std. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912081283), received between Jan 8, 2018 and Jan 8, 2018 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K092331); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN UNSTABLE TOTAL HIP REVISION.
Patient problems: No Information
MAUDE report 7171453 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092331. One submission often covers many models, so check the product and lot details in each record.
- Z-1191-2017 · Jan 10, 2017 · TerminatedLIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Mors
Other Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) devices
- BIOLOX DELTA 1365-32-730Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)93 reports
- RingLoc® Hip System 103531Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)1 recall0 reports
- BIOLOX DELTA 1365-28-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- ASPHERE 1365-52-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)39 reports
- ASPHERE 1365-05-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- ASPHERE 1365-06-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- Taperloc Complete Micro Primary Femoral 51-107130Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)23 reports
- Taperloc Complete Micro Primary Femoral 51-107120Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)19 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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