Tri-plus 138-2200Recalls & reported problems
Ortho Development Corporation · 12/14 CoCr Fem Head 22mm + 0 · Class 2 · Implant
Data updated Oct 13, 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 00822409016174), received between Jun 15, 2020 and Jun 15, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Arthralgia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2020Migration; Migration
THE PATIENT EXPERIENCED POSTOPERATIVE DISLOCATION AFTER BIPOLAR HIP ARTHROPLASTY. AT THE INITIAL SURGERY ON (B)(6) 2019, IT WAS CONFIRMED THAT THE CUP AND HEAD WERE FIRMLY ATTACHED. SUBSEQUENT TO THE INITIAL SURGERY, AN X-RAY DETERMINED THAT THE HEAD WAS DISLOCATED FROM THE CUP AND THE CUP WAS DISLOCATED FROM THE ACETABULUM. ON (B)(6) 2019, THE SURGEON PERFORMED A REVISION TO REPLACE THE CUP AND THE FEMORAL HEAD. THIS REPORT IS TWO OF TWO FOR THIS INCIDENT.
Patient problems: Arthralgia
MAUDE report 10153524 ↗
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- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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