Compress® Device 178354Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Compress Device (71)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304509078), received between Feb 26, 2021 and Sep 16, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 reports).
1 FDA recall record name this device's identifier.
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 16, 2026.
Reports received per month
Recalls naming this device
- Aug 21, 2019Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0519-2020 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture3
- Migration2
Patient problems
- Failure of Implant2
- Pain2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 50793046 ↗InjuryOct 2, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20351604 ↗InjuryJun 7, 2024Migration; Migration
IT WAS REPORTED THE PATIENT FELT A PAIN AROUND ONE MONTH POST REVISION. VISITED THE HCP FOR EXAMINATION EARLY MAY AND THE X-RAYS SHOWED SHORTENING BETWEEN THE ANCHOR PLUG AND SPINDLE AS IN THE PREVIOUS VISIT. NO REVISION HAS TAKEN PLACE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19483121 ↗InjuryDec 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OSS PROCEDURE. SUBSEQUENTLY, THE PATIENT STARTED EXPERIENCING PAIN WHILE SQUATTING. IT WAS DETERMINED THAT THE ANCHOR PLUG CONTACTED THE SPINDLE AND BROKE. THE SURGEON ALSO FOUND THE ANCHOR PLUG HAD MIGRATED ABOUT 1 CM. A SUCCESSFUL REVISION WAS COMPLETED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 18367883 ↗InjuryFeb 26, 2021Fracture; Fracture
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385203 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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 · each recall links to the FDA recall notice
- 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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