DJO SURGICAL 438-01-003Recalls & reported problems
Djo, LLC · STEM, HIP, POROUS COATED, PRESS FIT, R120 SIZE3 · Class 2 · Implant
All models of DJO SURGICAL (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912085861), received between Feb 21, 2017 and Aug 8, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Device Dislodged or Dislocated1
- Disconnection1
- Separation Failure1
Patient problems
- No Code Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2019Separation Failure; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO MODULAR R120 STEM HAVING FAILED/DISASSOCIATED WITH THE MODULAR FEMORAL NECK. REVISION SURGERY WAS REQUIRED TO PREVENT FURTHER DAMAGE TO PATIENT.
Patient problems: No Information
MAUDE report 8874101 ↗InjuryFeb 21, 2017Disconnection; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE R120 MODULAR NECK DISCONNECTING AND CAUSING THE HIP TO DISLOCATE. A NECK REPLACEMENT WAS NOT AN OPTION FOR THE R120, SO A FULL REVISION WAS COMPLETED WITH A LIMA.
Patient problems: No Code Available
MAUDE report 6347242 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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