Trident 542-11-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327037227), received between Mar 10, 2017 and Nov 25, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION. CUP, SCREWS, INSERT, AND HEAD REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23642578 ↗
• InjuryJun 21, 2022Material Erosion; Material Erosion

  THE FOLLOWING WAS REPORTED: I WAS IN A DEEP SQUAT, ONE I HAD DONE MANY TIMES BEFORE, AND MY IMPLANT FAILED AND SLIPPED OUT OF THE SOCKET. UPDATE PER CONVERSATION WITH PATIENT 05/25/2022: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2022, PATIENT WAS IN A "DEEP SQUAT" AND THE LEFT HIP "FELL OUT TO THE BACK". PATIENT NOTED THAT PRIOR TO REVISION, SURGEON INDICATED POTENTIAL "STEM HITTING CUP AND LINER BREAKAGE" (PATIENT IS UNSURE IF LINER WAS METAL OR POLY). PATIENT ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT. PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2022. PATIENT HAS NOT RETURNED TO SURGEON YET FOR FOLLOW UP AND IS UNSURE AT THIS TIME WHAT PARTS WERE REVISED. PATIENT WILL SUPPLY MEDICAL RECORDS. UPDATE 13/JUNE/2022 WG: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019 (PI 2139849). LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14753243 ↗
• InjuryNov 29, 2021Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "REVISION SURGERY DONE ON A RIGHT TOTAL KNEE. THE REVISION WAS DONE FOR INSTABILITY. NO OTHER INFORMATION IS AVAILABLE." A CR FEMORAL COMPONENT AND CS INSERT WERE EXPLANTED AND REPLACED WITH A PS FEMORAL COMPONENT WITH TS INSERT, FEMORAL AUGMENT, AND FEMORAL FIXATION PEG. SPOKE TO REP: REP CONFIRMED THAT THERE ARE NO ALLEGATIONS OF ISSUES ARISING FROM BONE CUTS MADE IN THE PRIMARY MAKO PROCEDURE. REP ALSO CONFIRMED THERE WERE NO ADDITIONAL INTRA-OPERATIVE OBSERVATIONS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Joint Laxity; Pain

  MAUDE report 12888536 ↗
• 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 JUNE 13, 2011 AND WAS REVISED ON MAY 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 7, 2020: IT WAS REPORTED THAT "CATASTROPHIC FAILURE AND FRACTURING OF RIGHT FEMORAL STEM TRUNNION AND DISASSOCIATION OF THE HEAD ... LOOSE ACETABULAR SOCKET." " ... SIGNIFICANT AMOUNT OF METALLIC DEBRIS ... TRUNNION COMPLETELY WORN DOWN TO NEARLY A PENCIL POINT ... STEM REMOVED WITH EXTRACTOR, OSTEOTOMES AND BURR ... ACETABULUM GROSSLY LOOSE.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Reaction

  MAUDE report 10457078 ↗
• 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, DEVICE RECALL 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: Bone Fracture(s); Inflammation; Injury; Pain; Reaction

  MAUDE report 10454008 ↗
• 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 10294561 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION DUE TO DISLOCATION PATIENT CALLED STATED HE HAD A LEFT HIP REPLACEMENT DONE ON (B)(6) 2007. HE STATED HE HAD A DISLOCATION A FEW DAYS AFTER HIS SURGERY, AND WAS REVISED ON (B)(6) 2007. PATIENT DID NOT SPECIFIED IF THE HEAD CAME OUT OF THE LINER OR THE LINER CAME OUT OF THE SHELL. HE REPORTED THAT HE IS CURRENTLY FEELING PAIN AND DISCOMFORT AND WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF A RECALL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9079549 ↗
• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A 56MM TRIDENT PSL HA CLUSTER SHELL, X3 LINER, CERAMIC HEAD AND SLEEVE WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER FEMORAL HEAD. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS OR INTRA-OPERATIVE FINDINGS AGAINST THE LINER, HEAD, OR SLEEVE. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8930725 ↗
• InjuryAug 13, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  AS REPORTED VIA THE CONTACT US EMAIL FORM: IN (B)(6) 2018 PATIENT HAD BILATERAL TOTAL HIP REPLACEMENT WITH THE STRYKER TRIDENT PSL. IN APPROXIMATELY (B)(6) 2018 PATIENT STARTED EXPERIENCING SYMPTOMS IN RIGHT HIP. AT THE END OF (B)(6) X-RAYS CONFIRMED MECHANICAL FAILURE OF THE RIGHT HIP JOINT. PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6). WAS THIS PRODUCT RECALLED? DO YOU HAVE A CLAIMS PROCESS RELATED TO THE TYPE OF PRODUCT LIABILITY? UPDATE 13/JUNE/2022: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022. ADDITIONAL INFORMATION REPORTED VIA: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT. PATIENT NOTED HE HAS THE LINER BUT WILL CONSULT WITH AN ATTORNEY PRIOR TO SEN

  Patient problems: Ambulation or Postural Difficulties; Injury; Metal Related Pathology; Pain

  MAUDE report 8887641 ↗
• InjuryMay 9, 2019Unstable; Unstable

  SURGEON COMMENTED THAT PATIENT THOUGHT HIS CUP WAS PART OF A RECALL AND WANTED A SMALLER HEAD. SURGEON ALSO COMMENTED THE POSSIBILITY OF ISSUES WITH PATIENTS PAPAS TENDON. UPDATE (B)(6) 2019: SPOKE TO REP. PROVIDED CATALOG AND LOT CODE FOR THE SHELL WERE NOT PART OF ANY RECALL. A PREVIOUS SURGEON ADVISED THE PATIENT THAT THE 40MM FEMORAL HEAD WAS TOO LARGE FOR THE PATIENT, AND PATIENT HAD A COMPLAINT OF INSTABILITY.

  Patient problems: Injury

  MAUDE report 8595850 ↗
• InjuryNov 1, 2018Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  DR. (B)(6) REPORTED THAT PATIENT REPORTED TO EMERGENCY DEPARTMENT AT THE (B)(6) HOSPITAL WITH A DISLOCATED RIGHT HIP PROSTHESIS. IMAGING POST RELOCATION SHOWING DISARTICULATION OF STRYKER ADM INSERT FROM FEMORAL STEM HEAD. PLANNED REVISION SURGERY FOR (B)(6). NOTE: THIS IS A REPEAT OCCURRENCE FOR THE SAME PATIENT AND PROSTHESIS COMBINATION. UPDATE: MEDICAL REVIEW CONFIRMS DISLOCATION OF THE ADM POLY LINER FROM THE MDM LINER, CUP MALPOSITION THAT NOT ADDRESSED AT PREVIOUS REVISION AND IMPINGEMENT OF THE STEM NECK AGAINST THE ACETABULAR COMPONENT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8030701 ↗
• InjuryOct 3, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON REPORTED THAT THE SHELL HAD AN EXCESSIVE AMOUNT OF OFFSET (IT WAS NOT REPORTED TO THE REP IF THE SHELL WAS IMPLANTED THAT WAY OR IF THE SHELL MIGRATED). A SHELL, MDM LINER CONSTRUCT AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A 36 +0 CERAMIC HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7931305 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO IMPINGEMENT (THE STEM WAS IN CONTACT WITH THE PELVIS OR NECK OF THE SHELL. NO DISASSOCIATION OR DISLOCATION WAS REPORTED). A HEAD AND LINER (IMPLANTED (B)(6) 2017), STEM AND SHELL (IMPLANTED IN 2014) WERE REVISED TO A RESTORATION MODULAR STEM, REVISION SHELL, AN ADM/MDM LINER CONSTRUCT, AND A FEMORAL HEAD.

  Patient problems: Injury

  MAUDE report 7712141 ↗
• InjuryNov 15, 2017Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  ANTERIOR DISLOCATION OF RIGHT HIP ON (B)(6) FOLLOWING RIGHT THA (B)(6) 2017. PATIENT PRESENTATION TO ED. PATIENT SAT DOWN FROM STANDING AND EXPERIENCED A SUDDEN POP SENSATION IN ANTERIOR GROIN. PRESENTED TO ED. PHYSICIAN(S) PERFORMED A CLOSED REDUCTION OF DISLOCATED RIGHT HIP AND HIP X-RAY. BASED ON THE INVESTIGATION RESULTS, SHELL MALPOSITION WAS CONFIRMED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7032490 ↗
• InjuryApr 12, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT STATED HE FELL DOWN A FLIGHT OF STAIRS. SURGEON BROKE PATIENT PELVIC BONE DURING LEFT HIP SURGERY DURING IMPLANTATION. PATIENT SAYS HIS FEMUR AND TAILBONE HURT BUT X-RAYS LOOK FINE.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 6487063 ↗
• InjuryMar 10, 2017Loss of Osseointegration; Loss of Osseointegration

  WAS NOTIFIED FOR A HIP REVISION WHERE CERAMIC HEADS AND SLEEVES WHERE REQUESTED TO BE AVAILABLE. THE CASE WAS A REVISION OF A LOOSE CUP AND INSERT WITH A HEAD SWAP. THE SURGEON REPLACED THE STRYKER CUP AND INSERT WITH ZIMMER AND REPLACED A STRYKER 40MM LFIT HEAD WITH A 40MM UNIVERSAL CERAMIC HEAD AND A -2.5 C-TAPER SLEEVE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 6396743 ↗