Trident 623-00-36GRecalls & reported problems
Howmedica Osteonics Corp. · 0 Degree Polyethylene Insert · Class 2 · Implant
All models of Trident (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Howmedica Trident hip insert is a plastic liner placed in the hip socket during hip replacement. Reports mostly describe infections needing washout or removal of parts, hip dislocations where the joint slipped out of place, and pain leading to revision surgery. There are 26 reports naming its identifier, with no deaths and 23 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327039528), received between Jan 9, 2018 and Oct 31, 2025 — classified as 23 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information13
- Device Dislodged or Dislocated6
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Insert2
- Degraded1
- Inadequacy of Device Shape and/or Size1
- Material Distortion1
- Positioning Problem1
Patient problems
- Injury12
- Unspecified Infection10
- Joint Dislocation4
- Pain4
- No Consequences Or Impact To Patient2
- Ambulation or Postural Difficulties1
- Extraskeletal ossification1
- Hematoma1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: "DEVICE IMPLANTED IN 2017. APPROX (B)(6) 2023, PATIENT REPORTS THEY WERE AT HOME WHEN THE RIGHT SIDE OF THEIR BODY DROPPED AND THEY EXPERIENCED EXCRUCIATING PAIN. AN AMBULANCE WAS CALLED, AND THEY WERE TAKEN TO THE HOSPITAL. RECEIVED REVISION SURGERY.
Patient problems: Pain
MAUDE report 23439639 ↗InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS MDR IS FOR PAIN AND REVISION FOR SUSPECTED INFECTION. PATIENT HAD PAIN, SURGEON THOUGHT WAS INFECTED PLAN TO REVISE ACETABULAR COMPONENTS WHEN IN SURGERY PUS PRESENT DECIDED TO REMOVE ALL COMPONENTS AND CEMENT CUP AND STEM TO COME BACK AND REVISE IN 6 WEEKS. WHEN TRIALING NEW EXETER STEM REALIZED THE FEMUR HAD A FRACTURE, CABLES APPLIED TO FRACTURE AND STEM EXCHANGED TO 37.5 #1.
Patient problems: Pain; Unspecified Infection
MAUDE report 19656614 ↗InjuryMay 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
[TRIDENTII-03-009RESEARCH ] PRIMARY SURGERY WAS COMPLETED ON (B)(6) 2021. PATIENT DISLOCATED DUE TO A PROHIBITED POSITION ON (B)(6) 2021. RECONSTRUCTION OF DISLOCATION WITHOUT BLOOD WAS PERFORMED AND PATIENT OUTCOME WAS RECOVERY.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16984938 ↗InjuryApr 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE POLY LINER. THE HEAD AND LINER WERE REVISED TO A CERAMIC HEAD WITH A CONSTRAINED LINER.
Patient problems: Joint Dislocation
MAUDE report 16820535 ↗InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: THE PATIENT HAD A PRIMARY THA ON (B)(6) 2021. THE PATIENT DEVELOPED AN INFECTION OF THE RIGHT HIP AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021.
Patient problems: Unspecified Infection
MAUDE report 15307911 ↗InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "HOSPITAL CALLED ME LATE YESTERDAY AFTERNOON ASKING ME TO REMOVE THE POLY IN THE PSL CUP PATIENT HAS IMPLANTED. PATIENT IS INFECTED AND DR. DOING A WASH OUT, TAKING THE POLY LINER OUT, AND THE HEAD, THEN REPLACING ITEMS WITH STERILE COMPONENTS. NOTHING WAS LOOSE OR BROKEN. RIGHT SIDE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." THE POLY INSERT (IMPLANTED (B)(6) 2017) AND BIOLOX DELTA HEAD (IMPLANTED (B)(6) 2020) WERE REVISED TO A NEW POLY AND COBALT L-FIT HEAD.
Patient problems: Unspecified Infection
MAUDE report 11035327 ↗InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALL IMPLANTS FROM A THA WERE EXPLANTED DUE TO AN ACTIVE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10810295 ↗InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. A 0° 36MM G POLY INSERT AND 36 + 5MM CERAMIC V40 HEAD WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10751802 ↗InjurySep 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. SURGEON REPORTED THE CAUSE OF PAIN TO BE HETEROTOPIC OSSIFICATION AND THAT THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS. A HEAD AND LINER EXCHANGE WITH DEBRIDEMENT WAS PERFORMED.
Patient problems: Extraskeletal ossification; Pain
MAUDE report 10601087 ↗InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATION OF A COMPETITOR HEAD FROM A STRYKER LINER. THE SURGEON WANTED TO ADJUST THE SHELL POSITIONING, AND REVISED THE SHELL, 3 SCREWS, LINER AND COMPETITOR HEAD TO ANOTHER SHELL WITH MDM LINER, ADM/ MDM INSERT, AND ANOTHER COMPETITOR HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Injury; Joint Dislocation
MAUDE report 10507968 ↗InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO CHRONIC DISLOCATION. A 36 +5 CERAMIC HEAD AND 36G POLY LINER WERE REVISED TO A 28 +5 CERAMIC HEAD AND SLEEVE, AND A 28G CONSTRAINED INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.
Patient problems: Injury
MAUDE report 10507261 ↗InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THIS PI IS FOR THE REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2019. POSTOPERATIVE DIAGNOSIS: PATIENT HAD TOTAL LEFT HIP ARTHROPLASTY SEVERAL YEARS AGO (OUTSIDE CORS SCOPE). PATIENT HAD PERSISTENT AND PROGRESSIVE PAIN IN THE LEFT HIP FOR MANY YEARS. X-RAYS CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. REVISION OF BOTH ACETABULAR AND FEMORAL COMPONENTS (B)(6) 2018. PATIENT HAD CHRONIC INFECTION AFTER REVISION ARTHROPLASTY, AND UNDERWENT LEFT HIP ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC- LOADED CEMENT SPACER (B)(6) 2018. THIS WAS REPORTED IN (B)(4). THE PATIENT PRESENTED DRAINAGE FROM LEFT THIGH INCISION AND IN (B)(6) 2019 HAD A RESECTION ARTHROPLASTY WITH ANTIBIOTIC-LOADED CEMENT SPACER FOR HIS INFECTED LEFT HIP. IN (B)(6) 2019, PATIENT UNDERWENT TWO- STAGE REIMPLANTATION.
Patient problems: Injury; Unspecified Infection
MAUDE report 8821682 ↗MalfunctionMay 28, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE LINER COULD NOT BE LOCKED INTO THE SHELL. ANOTHER LINER OF THE SAME CATALOG WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A 5-10 MINUTE DELAY. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8645376 ↗InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
POSTOPERATIVE DIAGNOSIS: PATIENT HAD TOTAL LEFT HIP ARTHROPLASTY SEVERAL YEARS AGO (OUTSIDE CORS SCOPE). PATIENT HAD PERSISTENT AND PROGRESSIVE PAIN IN THE LEFT HIP FOR MANY YEARS. X-RAYS CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. REVISION OF BOTH ACETABULAR AND FEMORAL COMPONENTS (B)(6) 2018. PATIENT HAD CHRONIC INFECTION AFTER REVISION ARTHROPLASTY, AND UNDERWENT LEFT HIP ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC- LOADED CEMENT SPACER (B)(6) 2018.
Patient problems: Injury; Unspecified Infection
MAUDE report 8568926 ↗InjuryFeb 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
POSSIBLE INFECTION, I & D WASHOUT. SURGEON REMOVED LINER/HEAD. WASHOUT AND NEW LINER/HEAD IMPLANTED. NO COMPLICATIONS.
Patient problems: Injury; Unspecified Infection
MAUDE report 8345619 ↗MalfunctionJan 14, 2019Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem
X3 0 DEGREE 36MM G ALPHA CODE LINER LOCKING MECHANISM FAULTY. LINER TAKEN OUT WITHOUT ANY COMPLICATIONS AND REPLACED WITH NEW LINER. NO COMPLICATIONS ON REIMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 8245786 ↗InjuryDec 26, 2018Degraded; Degraded
AN 88-YEAR-OLD MAN, BMI 24, PRESENTED TO THE CLINIC WITH COMPLAINTS OF PAIN AND A CRACKING SENSATION IN HIS RIGHT HIP APPROXIMATELY SIX MONTHS, NINE YEARS POST PRIMARY RIGHT THA. DURING THE INITIAL PROCEDURE, THE PRIMARY COMPONENTS UTILIZED AN ACCOLADE #3 STEM WITH A 127-DEGREE NECK-SHAFT ANGLE AND +5 36MM L-FIT HEAD. RADIOGRAPHIC IMAGES OF THE RIGHT HIP SHOWED AN APPARENT TRUNNION FRACTURE WITH SIGNIFICANT ASYMMETRIC WEAR OF THE POLYETHYLENE LINER WITHIN THE ACETABULAR COMPONENT. PREOPERATIVE BLOODWORK REVEALED NORMAL LEUKOCYTES AND NORMAL-RANGE C-REACTIVE PROTEIN (CRP) AND ERYTHROCYTE SEDIMENTATION RATE (ESR). THUS, THE PATIENT WAS CONSENTED FOR REVISION THA FOR A PRESUMED TRUNNION FRACTURE. INTRAOPERATIVE ASSESSMENT REVEALED MARKED HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER OF THE RIGHT FEMUR, EXTENDING INTO THE GLUTEUS MAXIMUS, WHICH WAS EXCISED AND DEBRIDED THOROUGHLY. THOUGH THE FEMORAL HEAD WAS INTACT AND SHOWED NO GROSS SIGNS OF WEAR, THERE WAS COMPLETE DISSOCIATION FROM THE FEMORAL STEM. THERE WERE ALSO SIGNIFICANT SIGNS OF METALLOSIS WITH METAL-STAINED DEBRIS AND GRANULATION TISSUE, WHICH EXTENDED DEEP TO THE MARGINS SURROUNDING THE ACETABULAR SHELL. INTERESTIN
Patient problems: Inflammation; Injury; Unspecified Infection
MAUDE report 8196261 ↗InjuryDec 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED TO REP). A STRYKER STEM, METAL HEAD, AND LINER WERE REVISED TO A COMPETITOR STEM AND HEAD WITH A STRYKER LINER.
Patient problems: Injury; Pain
MAUDE report 8164855 ↗InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2013. RESECTION ARTHROPLASTY OF THE RIGHT INFECTED HIP PROSTHESIS. THEN THE PATIENT UNDERWENT RIGHT HIP REVISION WITH ANTIBIOTIC CEMENT SPACER ON (B)(6) 2018...I&D WITH WASH-OUT AND WOUND VAC PLACED.
Patient problems: Injury; Unspecified Infection
MAUDE report 7970066 ↗InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
AS PER MEDICAL REVIEW FOR PER (B)(4) STATED " ON (B)(6) 2010 THE PATIENT WAS ADMITTED FOR AN INCISION AND DRAINAGE OF AN INCISIONAL HEMATOMA AND AN OPEN REDUCTION AND INTERNAL FIXATION OF A GREATER TROCHANTERIC FRACTURE ON THE LEFT.
Patient problems: Hematoma; Increased Sensitivity; Injury
MAUDE report 7907965 ↗InjurySep 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
X-RAY WAS NOTED TO SHOW SIGNIFICANT HETEROTOPIC OSSIFICATION OF THE LEFT HIP AND MODERATE DEGENERATIVE JOINT DISEASE OF THE RIGHT HIP. THE RANGE OF MOTION OF THE RIGHT HIP WAS GREATER THAN THAT OF THE LEFT. THE RIGHT HIP FLEXED TO 120° COMPARED TO 90° ON THE LEFT, AND ABDUCTED 20° COMPARED TO 10° ON THE LEFT".
Patient problems: Loss of Range of Motion
MAUDE report 7900656 ↗InjuryAug 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. SURGEON REPORTED THE PRESENCE OF EXTENSIVE HETEROPTIC BONE AND SOFT TISSUE LAXITY. PATIENT WAS REVISED FROM A POLY LINER AND CERAMIC HEAD +0 TO AN ADM/MDM LINER CONSTRUCT AND A SMALLER CERAMIC HEAD +5.
Patient problems: Injury; Joint Dislocation
MAUDE report 7754515 ↗InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY.
Patient problems: Injury
MAUDE report 7323012 ↗InjuryJan 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF AN IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED.
Patient problems: Injury
MAUDE report 7202067 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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