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Trident 623-10-36FRecalls & reported problems

Howmedica Osteonics Corp. · 10 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 Howmedica Osteonics Trident hip insert is a semi-constrained polyethylene liner used in uncemented hip replacements. Reports mainly describe revision surgeries due to infection, instability, or dislocation of the femoral head from the liner. There are 40 adverse event reports naming this device, with no deaths and 36 injuries. There are no recalls naming 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
40
Deaths reported
0
Injuries reported
36
Recalls naming it
0

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613327039924), received between Feb 22, 2017 and Nov 21, 2025 — classified as 36 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Insufficient Device Problem Information19
  • Device Dislodged or Dislocated7
  • Adverse Event Without Identified Device or Use Problem4
  • Degraded3
  • Unstable3
  • Difficult to Insert2
  • Fitting Problem2
  • Contamination1

Patient problems

  • Injury20
  • Unspecified Infection13
  • Pain8
  • Joint Dislocation6
  • No Consequences Or Impact To Patient4
  • Ambulation or Postural Difficulties2
  • Joint Laxity2
  • Cyst(s)1

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED "PATIENT'S RIGHT HIP REVISED DUE TO INFECTION. ALL IMPLANTS EXPLANTED, NO RETURNS PER HOSPITAL POLICY".

    Patient problems: Unspecified Infection

    MAUDE report 23617873 ↗
  • InjuryApr 1, 2024Unstable; Unstable

    PATIENT REVISED DUE TO INSTABILITY. THIS IS THE RIGHT SIDE. DR. THOUGHT THE PATIENT WAS IMPINGING POSTERIORLY SO WE PUT IN A NEUTRAL LINER. WE WASTED A LINER AS IT STILL FELT UNSTABLE, AND WE IMPLANTED THE 0° ECCENTRIC LINER LISTED ON THE SHEET. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

    Patient problems: Joint Laxity

    MAUDE report 19015521 ↗
  • InjuryJun 2, 2023Degraded; Unstable; Degraded; Unstable

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND WEAR OF THE LINER. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Laxity

    MAUDE report 17047604 ↗
  • InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED: INDEX AND REVISION SURGERIES OF A RIGHT TOTAL HIP. REVISION SURGERY WAS DONE DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL. A PORTION OF THE PRIMARY OPERATIVE REPORT AND REVISION USAGE WERE PROVIDED. A HEAD AND LINER WERE REVISED.

    Patient problems: Unspecified Infection

    MAUDE report 15316937 ↗
  • InjuryAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE HEAD FROM THE LINER. HEAD AND LINER WERE REVISED TO A NEW HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 15204028 ↗
  • InjuryJun 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "CHRONIC DISLOCATION AND TRUNNIONOSIS." CONFIRMED DISLOCATION WAS OF THE HEAD FROM THE LINER. THE STEM HAD PREVIOUSLY BEEN REPORTED FOR TRUNNIONOSIS AND HAD BEEN LEFT IN-SITU. A HEAD, 10° LINER, AND SLEEVE WERE REVISED TO ANOTHER HEAD, CONSTRAINED INSERT, AND SLEEVE (THE STEM WAS AGAIN RETAINED).

    Patient problems: Joint Dislocation

    MAUDE report 14826743 ↗
  • InjuryMar 27, 2022Degraded; Degraded

    THIS PI IS FOR LEFT HIP: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6), 2014. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAD NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE. UPDATE: 07 MARCH 2022: BASED ON THE MEDICAL REVIEW: THIS INQUIRY REPORTS THE FAILURE OF A LEFT TOTAL HIP REPLACEMENT PERFORMED IN 2014 AND REVISED IN 2022 FOR MECHANICAL WEAR OF THE POLYETHYLENE COMPONENT, TRUNNIONOSIS AND ELEVATED ION LEVELS.

    Patient problems: Ambulation or Postural Difficulties

    MAUDE report 13925279 ↗
  • InjuryMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE LINER. THE HEAD AND LINER WERE REVISED TO AN ADM/ MDM LINER CONSTRUCT AND A NEW FEMORAL HEAD. REP REPORTED THAT HE MAY BE ABLE TO PROVIDE THE PRIMARY USAGE AND THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 13705528 ↗
  • InjuryMar 1, 2022Degraded; Mechanical Problem; Degraded; Mechanical Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. PRIOR TO REVISION SURGEON REPORTED HE BELIEVED THERE WAS IMPINGEMENT OF THE LINER ON THE STEM, AND INTRA-OPERATIVELY SURGEON REPORTED HE BELIEVED HE SAW WEAR ON THE LIP OF THE LINER. THE 36 -5 METAL HEAD AND 10° F LINER WERE REVISED TO A CERAMIC HEAD WITH -2.5 SLEEVE AND 0° F LINER.

    Patient problems: Loss of Range of Motion; Pain

    MAUDE report 13637073 ↗
  • InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS PI IS FOR REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2019. WHILE GATHERING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021 THE REP WAS TOLD OF A PRIOR REVISION ON (B)(6) 2019 DUE TO PATIENT COMPLAINT OF PAIN. A 36F 10° INSERT WAS EXCHANGED FOR ANOTHER OF THE SAME CATALOG. REP WAS NOT PRESENT FOR THE PROCEDURE IN 2019. REP PROVIDED IMPLANT INFORMATION FOR ALL SURGERIES AND THE PRIMARY OPERATIVE REPORT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Pain

    MAUDE report 11675296 ↗
  • InjuryMar 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. SPOKE TO REP: NOTHING WAS NOTED INTRA-OPERATIVELY (NOTHING WAS LOOSE, BROKEN, ETC). REP CONFIRMED THAT HE MAY BE ABLE TO PROVIDE DATE OF IMPLANT AND LOT CODES BUT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Pain

    MAUDE report 11562687 ↗
  • InjuryJan 6, 2021Naturally Worn; Naturally Worn

    THE END USER HAS REPORTED: ACCOLADE STEM FAILURE AT THE NECK OF THE STEM. REVIEWED PHOTOS OF DEVICES SHOWS LINER WEAR.

    Patient problems: Ambulation or Postural Difficulties; Failure of Implant; No Information

    MAUDE report 11123882 ↗
  • InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PSOAS PAIN. A C-TAPER HEAD AND X3 INSERT WERE REVISED TO A BIOLOX DELTA TAPER FEMORAL HEAD AND ADM/MDM LINER CONSTRUCT. THERE ARE NO ALLEGATIONS AGAINST THE IMPLANT AND REP CONFIRMED THAT THE EXPLANTS ARE NOT AVAILABLE FOR RETURN AND NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Pain

    MAUDE report 11113610 ↗
  • InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2007 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE JULY 31, 2020: CLINICAL CONSULTANT'S REVIEW INDICATED THAT THERE WAS AN ACETABULAR FRACTURE AND THAT THE LINER WAS WORN.

    Patient problems: Inflammation; Injury; Reaction

    MAUDE report 10454007 ↗
  • InjuryJun 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION. THE PATIENT'S STEM (IMPLANTED (B)(6) 2015), SLEEVE, FEMORAL HEAD, LINER, SHELL AND SCREWS (IMPLANTED ON (B)(6) 2019, REVISION REPORTED) WERE REVISED AND A SPACER PLACED. REP PROVIDED USAGE SHEETS FROM PRIMARY AND PREVIOUS SURGERIES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 10161524 ↗
  • InjuryApr 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT: "SURGERY SHEET FOR HIP REVISION PERFORMED THIS MORNING. PT. PRESENTED WITH A DISLOCATED LEFT HIP FOLLOWING CLOSED REDUCTION IN THE ED FOR PREVIOUS DISLOCATION, PT¿S HIP WAS DEEMED UNSTABLE AND REQUIRING SURGICAL INTERVENTION. THE X3 INSERT AND BIOLOX DELTA CERAMIC HEAD WERE SWAPPED FOR A MDM METAL LINER AND MDM/LFIT HEAD CONSTRUCT. ACETABULAR SHELL, SCREWS, AND FEMORAL STEM WERE LEFT IN PLACE. NO COMPLAINTS HAVE BEEN MADE AGAINST THE IMPLANTS."

    Patient problems: Injury; Joint Dislocation

    MAUDE report 9972958 ↗
  • InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A HEAD/ LINER EXCHANGE WITH WASHOUT WAS PERFORMED. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 9588303 ↗
  • InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED, AND A 36F POLY LINER WAS SWAPPED FOR ANOTHER 36F POLY LINER. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND A PRE-REVISION X- RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 9273987 ↗
  • InjurySep 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    PATIENT IS PART OF THE TRITANIUM PRIMARY ACETABULAR SHELL STUDY AND REPORTED PAIN IN THE STUDY HIP DURING THE 6-YEAR VISIT. PATIENT STATES HE OCCASIONALLY HAS PAIN IN MUSCLES WHEN LIFTING LEG (EG TO GET INTO CAR). PAIN DOES NOT OCCUR ON STAIRS OR ALL THE TIME. PATIENT STATES PAIN IS NOT NEW BUT HAS NOT MENTIONED IT PREVIOUSLY. OPERATIVE SIDE IS RIGHT. PATIENT HAS NOT BEEN REVISED AS OF THE EVENT DATE.

    Patient problems: Pain

    MAUDE report 9087579 ↗
  • InjuryJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    DOCTOR REPORTED THAT PATIENT FELT A "POP" IN HIS HIP WHEN HE WAS ROLLING OVER IN HIS BED. DOCTOR DISCOVERED WHEN HE TOOK THE PATIENT BACK INTO THE OR THAT THE TRIDENT LINER HAD "SPUN OUT" OF THE SHELL. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE AND THE HOSPITAL HAS THROWN AWAY THE LINER. DOCTOR IMPACTED ANOTHER 623-10-36F LINER SUCCESSFULLY AND REFRESHED THE STEM WITH A NEW FEMORAL HEAD. UPDATE 03/JUNE/2019: SPOKE TO REP. THE SHELL WAS REPORTED WELL-FIXED AND WAS NOT REVISED.

    Patient problems: Injury

    MAUDE report 8734705 ↗
  • InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED OR IF INFECTING MICROORGANISM IDENTIFIED. POSSIBLE CAUSE OR CONTRIBUTOR TO INFECTION UNKNOWN). SURGEON PERFORMED AN IRRIGATION & DEBRIDEMENT WITH A HEAD AND LINER REVISION. PATIENT WAS REVISED TO A LINER OF THE SAME CATALOG AND A C-TAPER HEAD WITH SLEEVE. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 8727750 ↗
  • InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    PATIENT HAS INFECTION IN RIGHT HIP. TOTAL HIP REPLACEMENT WAS (B)(6) 2018. TRIDENT LINER AND FEMORAL HEAD REPLACED AND HIP WASHED OUT. SWABS AND SPECIMENS SENT. PATIENT HAD RECENT MELANOMA REMOVED FROM BACK THAT HAD EXCESS BLEEDING.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 8347689 ↗
  • InjuryFeb 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT UNDERWENT REVISION HIP SURGERY FOR A ONE-TIME HIP DISLOCATION. PRIMARY HIP SURGERY DONE VIA MAKO ON (B)(6) 2018.

    Patient problems: Injury; Joint Dislocation

    MAUDE report 8337269 ↗
  • InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    DR REPORTS PATIENT WAS A STATUS POST CONVERSION FROM AN IM NAIL TO A RESTORATION MODULAR HIP STEM/TOTAL HIP ON (B)(6) 2018. HE IS NOW INFECTED AND DR WOULD LIKE TO PERFORM A ONE STAGE WASHOUT WITH EXCHANGE OF STEM. IMPLANTS WERE REMOVED USING EXTRACTION TOOLS. THE LINER WAS REMOVED AS WELL. HE DECIDED TO LEAVE THE CUP IN PLACE. DR PROCEEDED TO WASH OUT THE WOUND. HE THEN REIMPLANTED A RESTORATION MODULAR STEM, HEAD AND NEW LINER. THE PROCEDURE WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE DUE TO EMR PASSWORD SECURED MEDICAL RECORDS. UPDATE 11/JANUARY/2019: REP REPORTED AFTER FIRST REQUEST FOR ADDITIONAL INFORMATION THAT THE IM NAIL WAS A COMPETITOR DEVICE, NO STRYKER DEVICES WERE REVISED.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 8304654 ↗
  • InjuryJan 23, 2019Unstable; Unstable

    IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A NOTE ON THE REVISION IMPLANT SHEET INDICATES "REVISED FOR INSTABILITY". X3 10° POLY INSERT AND 36 +5 C-TAPER BIOLOX CERAMIC HEAD WITH ADAPTER SLEEVE WERE REVISED TO A 28+8 LFIT V40 HEAD AND ADM/MDM LINER CONSTRUCT.

    Patient problems: Injury

    MAUDE report 8271930 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

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