Trident 623-00-36FRecalls & reported problems
Howmedica Osteonics Corp. · 0 Degree Polyethylene Insert · Class 2 · Implant
All models of Trident (160)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Trident polyethylene liner is a insert used in hip replacement implants. The 87 reports describe hip problems after implantation, mostly infections, pain, and the joint coming out of place, often requiring revision surgery, with no deaths and 86 injuries. No recalls name this device. Report volume is steady, at 1 in each of the past two 12-month periods.
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
- 87
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 07613327039535), received between Jan 5, 2017 and Feb 9, 2026 — classified as 86 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information53
- Device Dislodged or Dislocated14
- Adverse Event Without Identified Device or Use Problem9
- Unstable4
- Degraded2
- Material Deformation2
- Naturally Worn2
- Device Contamination with Chemical or Other Material1
Patient problems
- Injury54
- Unspecified Infection38
- Pain20
- Joint Dislocation15
- Ambulation or Postural Difficulties4
- Inflammation4
- Fall3
- Loss of Range of Motion3
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2026Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A STRYKER HIP (LEFT ) DUE TO INSTABILITY AND CHRONIC DISLOCATION (HEAD OUT OF THE LINER). NO VISIBLE SIGNS OF DAMAGE NOR WEAR. REMOVED HEAD AND LINER, REPLACED WITH AN MDM CONSTRUCT. NO FURTHER INFORMATION TO BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 24298567 ↗InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THIS PI IS FOR THE LEFT HIP. AS REPORTED: I RECEIVED A TOTAL HIP OF BOTH HIPS, THE FIRST, IN 2015 (R) AND 2017 (L). VIBRATIONS STARTED IN 2018. UPON INVESTIGATION OF THE FREQUENCIES, I LEARNED A BLE (BLUETOOTH LOW ENERGY) READING IDENTIFYING THE UUID (UNIVERSALLY UNIQUE IDENTIFIER) OF COMPETITOR MICROCHIP IS BEING EMITTED. PLEASE HELP ME IDENTIFY IF THE PARTS MAY HAVE BEEN FITTED WITH AFTERMARKET DEVICES. IT'S NOT ONLY ANNOYING BUT IT'S BECOMING PAINFUL.
Patient problems: Pain
MAUDE report 22050939 ↗InjuryFeb 15, 2023Device Damaged by Another Device; Device Damaged by Another Device
THERE WAS BACKSIDE WEAR-LIKE OSTEOLYSIS AROUND THE SCREW HOLE OF TRIDENT CUP. AN INDENTATION MADE BY THE SCREW HEAD WAS OBSERVED ON THE BACKSIDE OF THE LINER.
Patient problems: Osteolysis
MAUDE report 16382959 ↗InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PRE-OP DIAGNOSIS: CHRONIC PAIN FOLLOWING LEFT TOTAL HIP ARTHROPLASTY, INFECTION AND INFLAMMATION DUE TO LEFT HIP PROSTHESIS." A HEAD AND LINER WERE REVISED.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 15860579 ↗InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FOLLOW-UP QUESTIONNAIRE WAS COMPLETED BY THE SUBJECT WHERE THEY ANSWERED "NO" FOR SATISFACTION WITH THE RESULTS OF THE STUDY HIP REPLACEMENT. THE SUBJECT MENTIONED THAT THEY ARE NOT SATISFIED WITH THEIR HIP REPLACEMENT AND HAVE DAILY PAIN IN THE LEFT HIP. FURTHERMORE, THE SUBJECT EXPLAINED THAT THE THEY HAVE MORE PAIN NOW COMPARED TO BEFORE REPLACEMENT. NO ADDITIONAL DETAILS CAN BE PROVIDED AS THE QUESTIONNAIRES WERE ADMINISTERED VIA MAIL AND NO CLINICAL NOTES WERE OBTAINED.
Patient problems: Pain
MAUDE report 15821963 ↗InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6), 2014 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. HE STARTED EXPERIENCING THIGH PAIN, HAD A POSITIVE BONE SCAN WITH A PREOP DIAGNOSIS OF A LOOSE STEM. DURING REVISION SURGERY ON (B)(6), 2015 THE STEM WAS FOUND TO BE WELL FIXED HOWEVER THE PATIENT HAD A LEG LENGTH INEQUALITY AND HIS LINER AND HEAD WERE EXCHANGED.
Patient problems: Pain; Unequal Limb Length
MAUDE report 15733313 ↗InjurySep 12, 2022Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FRACTURED FEMORAL HEAD. INTRA-OPERATIVELY, THE HEAD WAS OBSERVED TO BE BROKEN INTO SEVERAL PIECES AND THE LINER WAS DAMAGED. SURGEON REPORTED THE PATIENT HAD HAD A FALL ONE MONTH PRIOR. THE HEAD AND LINER WERE REVISED. REP REPORTED THAT PICTURES CAN BE PROVIDED, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Fall
MAUDE report 15406485 ↗InjuryJul 13, 2022Degraded; Degraded
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. PER SALES REP: "PATIENT HAD A PERIPROSTHETIC FRACTURE. STEM WAS REVISED AND REPLACED WITH A LONGER MONOLITHIC STEM. SHELL STAYED INTACT AND LINER WAS REVISED TO AN MDM." COMPARING RECORDS FROM PATIENT'S PRIOR REVISION INDICATE THAT A SIZE 7 ANATO STEM, 36 +5 BIOLOX HEAD, AND 36F 0° LINER WERE REVISED. UPDATE: THERE WAS A FRACTURE LATERALLY AND SLIGHTLY DISTAL FROM THE GREATER TROCH. MINOR WEAR ON THE LINER AND HEAD WAS OBSERVED.
Patient problems: Bone Fracture(s)
MAUDE report 15008458 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED HE HAD A LEFT THA DONE ON (B)(6) 2020. PATIENT STATED THAT RIGHT AFTER SURGERY HE TOLD THE SURGEON THAT HIS LEG WAS LONGER. PATIENT STARTED TO EXPERIENCE PAIN RIGHT AFTER SURGERY AND THE PAIN HASN'T STOPPED. PATIENT HAD 6-8 SESSIONS OF PHYSICAL THERAPY. PATIENT STATED THAT DURING ONE OF HIS OFFICE VISITS THE SURGEON TOLD HIM HE HAD A LEG DISCREPANCY OF AN INCH LONGER. PATIENT SOUGHT A SECOND OPINION AND HAD AN MRI AND WAS GIVEN CORTISONE FOR THE PAIN. PATIENT IS LIMPING, HE¿S UNABLE TO BEND AND HAS BACK ISSUES. PATIENT WOULD LIKE TO CONFIRM IF HIS IMPLANTS ARE PART OF RECALL. PATIENT HAS BEEN EXPERIENCED DEPRESSION AS HE IS NOW UNABLE TO WORK AND THE ISSUES HE HAS BEEN EXPERIENCING. PATIENT WOULD LIKE ASSISTANCE WITH HIS HIP REVISION.
Patient problems: Ambulation or Postural Difficulties; Depression; Loss of Range of Motion; Pain; Unequal Limb Length
MAUDE report 13855858 ↗InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD PRIMARY TOTAL HIP REPLACEMENT AND NEEDED TO RETURN TO THE OR IN 11 DAYS DUE TO A PERI-PROSTHETIC FEMUR FRACTURE. DURING SURGERY THE ACETABULUM WAS NOTED TO BE LOOSE. ALL COMPONENTS EXCHANGED. THIS WAS REPORTED. THE PATIENT NOW PRESENTS WITH INFECTION, AND UNDERGOES REVISION WITH ALL COMPONENTS EXCHANGED WITH AN OFF-LABEL IMPLANT RECONSTRUCTION.
Patient problems: Unspecified Infection
MAUDE report 13677954 ↗InjuryMar 1, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
PATIENT HAD LEFT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH RECURRENT INSTABILITY. UNDERGOES REVISION ON (B)(6) 2021. FINDINGS: INSTABILITY AND HETEROTOPIC OSSIFICATION. ONLY HEAD, AND LINER ARE EXCHANGED.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity
MAUDE report 13630295 ↗InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENTS RIGHT POLY AND HEAD WERE SWAPPED DUE TO INFECTION. INITIAL IMPLANT DATE WAS (B)(6) 2020".
Patient problems: Unspecified Infection
MAUDE report 12125525 ↗InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT¿S RIGHT THA EXPLANTED DUE TO INFECTION. NO TRAUMA TO PATIENT. IMPLANTS KEPT BY HOSPITAL.
Patient problems: Unspecified Infection
MAUDE report 11784851 ↗InjuryMar 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "PATIENT HAS OSTEOLYSIS IN LEFT TOTAL HIP REPLACEMENT. THE SURGEON WOULD LIKE A REPORT OF FINDINGS." SPOKE TO THE REP. THE SURGEON DID NOT SPECIFICALLY REPORT WHERE THE OSTEOLYSIS IS. HOWEVER, THE REP NOTED THAT X-RAYS SHOW A 'BUBBLE' AROUND THE EDGES OF THE RIM OF THE SHELL. REP PROVIDED X-RAYS, A CT SLICE, AND PRIMARY USAGE. UPDATE: REVISION OCCURRED.
Patient problems: Osteolysis
MAUDE report 11413190 ↗InjuryFeb 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. ORIGINALLY, THE REASON FOR SURGERY WAS SUSPECTED SHELL LOOSENING. HOWEVER, AFTER REMOVING THE SCREW, THE SHELL WAS TOO WELL-FIXED TO BE REMOVED. SURGEON DECIDED TO REMOVE THE HEAD AND LINER. A 36F LINER AND 36 -5 BIOLOX HEAD WERE REVISED TO A 36 - 5 C TAPER BIOLOX HEAD WITH SLEEVE, AND ANOTHER 36F LINER. THE REP WAS NOT MADE AWARE OF ANY PATIENT COMPLAINTS AND CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Insufficient Information
MAUDE report 11384995 ↗InjuryFeb 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "CHRONIC DISLOCATING TOTAL LEFT HIP." A FEMORAL HEAD, POLY LINER, SHELL AND SCREW WERE REVISED. SPOKE TO REP. THE SURGEON WAS UNHAPPY WITH THE IN SITU SHELL'S POSITION AND WANTED TO CHANGE ITS VERSION.
Patient problems: Joint Dislocation
MAUDE report 11300591 ↗InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "DOCTOR EXPLANTED THE (RIGHT HIP CONSTRUCT) AND IMPLANTED AN ANTIBIOTIC SPACER CONSTRUCT DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP, WHO CONFIRMED NO FURTHER INFORMATION OR EXPLANTS WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 10807912 ↗InjuryOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT'S RIGHT HIP DISLOCATED ON THE WARD SAME DAY OF SURGERY. THEY RETURNED TO THEATRE AND THE FEMORAL HEAD WAS CHANGED FROM +5 TO +10. UPDATE 09/OCTOBER/2020: REP ALSO NOTED: AN UPDATE FROM THE SURGEON TODAY HE SUSPECTS THAT THE PATIENT HAD A HEART BLOCK AND BRADYCARDIA WHICH MADE HIM FALL ON THE WARD CAUSING THE DISLOCATION. THE PATIENT HAD A HEART RATE OF 25 FOLLOWING THE SECOND SURGERY.
Patient problems: Joint Dislocation
MAUDE report 10762895 ↗InjuryOct 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. A 36 +0 BIOLOX HEAD AND 36F 0° INSERT WERE REVISED TO AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND 28MM BIOLOX HEAD WITH SLEEVE. REP PROVIDED USAGE SHEETS FROM THE PRIMARY AND REVISION PROCEDURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 10698353 ↗InjuryOct 9, 2020Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SURGEON PERFORMED AN 'IRRIGATION & DEBRIDEMENT' OF A TOTAL HIP ARTHROPLASTY. WHEN REMOVING THE POLYETHYLENE INSERT HE NOTICED THAT THE SURFACE LOOKED DELAMINATED AND SCORED. IT WAS FURTHER REPORTED THAT THE INDEX OPERATION ONLY OCCURRED 4 WEEKS PRIOR ON (B)(6) 2020.
Patient problems: Failure of Implant
MAUDE report 10655501 ↗InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. REP STATED: "PT SEEMED TO BE DISLOCATING SO WE CHANGED HEAD/LINER TO MDM." A CERAMIC 36 + 7.5 V40 HEAD AND 36MM 0° POLY INSERT WERE REVISED TO AN LFIT V40 28 + 12 HEAD AND 28/52 46F X3 ADM/MDM LINER.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 10654377 ↗InjuryAug 27, 2020Unstable; Unstable
PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT UNDERWENT REVISION RIGHT TOTAL HIP FOR INSTABILITY ON (B)(6) 2020. HEAD, LINER AND STEM EXCHANGED.
Patient problems: Injury; Joint Dislocation; Joint Laxity
MAUDE report 10458098 ↗InjuryJul 20, 2020Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S RIGHT TOTAL HIP WAS REVISED DUE TO INSTABILITY.
Patient problems: Injury; Joint Dislocation; Pain
MAUDE report 10294565 ↗InjuryJun 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. NOTED ON THE USAGE SHEET: "INFECTION. 36MM -2.5 V40 HEAD AND 36MM 0° F LINER REMOVED. NO FURTHER INFORMATION WILL BE RELEASED DUE TO HOSPITAL POLICY." PATIENT WAS REVISED TO A 36MM -2.5 CERAMIC C-TAPER HEAD AND 36MM 0° POLY INSERT. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS.
Patient problems: Injury; Unspecified Infection
MAUDE report 10211889 ↗InjuryJun 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
SUBJECT REPORTED LEFT THIGH PAIN ON (B)(6) 2018. SPECIFICALLY, SUBJECT REPORTED INTERMITTENT, PERSISTENT THIGH PAIN WITH UNKNOWN ETIOLOGY. WORK UP FOR INFECTION OR LOOSENING WERE NEGATIVE. NORMAL APPEARANCE ON XRAY, 3-PHASE BONE SCAN, AND MRI. PI REPORTED THIGH PAIN AS UNCERTAIN TO DEVICE RELATION. SUBJECT REPORTED ONGOING PAIN DURING (B)(6) 2019 OFFICE VISIT. NOT A REVISION. PATIENT REPORTED THIGH PAIN, IMPLANT STILL IN PLACE.
Patient problems: Pain
MAUDE report 10179163 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page