Acetabular Insert 2099-2250Recalls & reported problems
Howmedica Osteonics Corp. · Acetabular Insert · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327031430), received between Aug 15, 2019 and Apr 26, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3201-2026 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Break1
Patient problems
- Injury1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE INNER BIPOLAR COMPONENT FROM THE OUTER COMPONENT OF A CONSTRAINED LINER. THE LINER AND FEMORAL HEAD WERE REVISED TO ANOTHER CONSTRAINED LINER AND FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 19195550 ↗InjuryAug 15, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE CONSTRAINED LINER OUT OF THE ACETABULAR SHELL. INTRA-OPERATIVELY, THE METAL RING OF THE CONSTRAINED LINER WAS REPORTED AS BROKEN ("SNAPPED"), AND THE INNER EDGE OF THE SHELL WAS REPORTED AS BEING ASSYMETRIC DUE TO WEAR. A 54MM SERIES II ACETABULAR SHELL, 50MM HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT, AND STRYKER FEMORAL HEAD WERE REVISED TO A TRIDENT II SHELL WITH 6 SCREWS, A TRIDENT CONSTRAINED LINER, AND ANOTHER STRYKER FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE FEMORAL HEAD. THE EXPLANTS ARE AVAILABLE FOR RETURN. OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Injury
MAUDE report 8897456 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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