Trident 542-11-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327037180), received between Jul 27, 2017 and Aug 8, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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.

• InjuryAug 8, 2024Malposition of Device; Malposition of Device

  PATIENT'S LEFT HIP WAS REVISED FOR CUP MALPOSITIONING AND FLUID COLLECTION AROUND THE JOINT. UPON REMOVAL OF THE FEMORAL HEAD FROM THE STEM THERE WAS CONSIDERABLE CORROSION OF THE TRUNNION VISIBLE. A NEW CUP WAS POSITIONED IN THE ACETABULUM TO ELIMINATE FEMORAL COMPONENT IMPINGEMENT. THE CORROSION WAS CLEANED FROM THE STEM TRUNNION AND A V-40 TO C-TAPER ADAPTER SLEEVE WAS USED TO IMPLANT A C-TAPER CERAMIC HEAD WITH A MDM LINER.

  Patient problems: Insufficient Information

  MAUDE report 19939988 ↗
• InjurySep 25, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION REPORTED AS GROSS TRUNNION FAILURE. BECAUSE OF THE AMOUNT OF METAL DEBRIS, LINER WEAR, AND IMPLANT STAINING, THE PATIENT'S ENTIRE HIP HAD TO BE REVISED. REP PROVIDED EXPLANT PICTURES AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 10586773 ↗
• InjuryAug 24, 2020Migration; Migration

  DOCTOR REPORTS PATIENT AT STATUS POST LEFT ANTERIOR HIP REPLACEMENT DONE APPROXIMATELY 2 WEEKS AGO MAY HAVE FALLEN AND NOW HAS AN ACETABULAR FRACTURE AND THE CUP HAS SHIFTED AS WELL AS PROTRUDED THROUGH THE MEDIAL WALL. DOCTOR REQUESTED TO REVISE THE ACETABULUM. THE CUP WAS CAREFULLY REMOVED AND THEN PREPARATION OF THE ACETABULUM WAS PERFORMED TO IMPLANT A TRITANIUM REVISION CUP. AFTER BONE GRAFTING THE MEDIAL WALL THE CUP WAS IMPLANTED AND MULTIPLE SCREWS WERE USED TO AUGMENT IT¿S FIXATION. SATISFIED WITH THE CUP A LINER WAS IMPACTED. IT WAS THEN NOTICED THE ACCOLADE CEMENTED STEM WAS LOOSE. DR DECIDED TO RE CEMENT A NEW STEM INTO THE EXISTING MANTLE. A TRIAL HEAD WAS USED TO CHECK STABILITY. A NEW HEAD WAS IMPLANTED AND THE SURGICAL SITE WAS CLOSED. THE SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE DUE TO EMR PASSWORD SECURED.

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

  MAUDE report 10446104 ↗
• InjuryAug 13, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A LOOSE ACETABULAR SHELL. PATIENT WAS REVISED TO STRYKER AND COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 10400521 ↗
• InjuryApr 2, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENTS HIP WAS REVISED FOR SUSPECTED INFECTION AND ACETABULAR LOOSENING. INFECTION LABS WERE FOUND TO BE NEGATIVE, BUT THERE WAS MARKED CORROSION ON THE FEMORAL STEM AND HEAD. PATIENTS ACETABULUM WAS REPLACED WITH A TRIDENT II MULTIHOLE SHELL AND 40MM LINER. FEMORAL HEAD WAS REPLACED WITH +0 40MM BIOLOX UNIVERSAL HEAD AND SLEEVE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9917997 ↗
• InjuryMar 30, 2020Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR REVISION 2 ON (B)(6) 2019. IT WAS REPORTED THROUGH A MEDWATCH (MW5092894) "DURING SECOND REVISION FOR A LOOSE STRYKER ACCOLADE II FEMORAL STEM, THE SURGEON NOTED MY TRIDENT PSL ACETABULAR CUP HAD SUBSIDED AND ASEPTIC LOOSENING HAD OCCURRED. THE FEMORAL STEM WAS SAID TO BE "GROSSLY LOOSE" AND THE SURGEON FELT THE SUBSIDED CUP HAD CONTRIBUTED ON THE LOOSENING OF THE STEM. THE PATHOLOGIST REPORTED THERE WAS 'SCANT NATIVE BONE ON THE CUP'. THIS THE SECOND STRYKER ACCOLADE II STEM I HAVE HAD REPLACED DUE TO 'NO BONE INGROWTH AND GROSS LOOSENING' IN 42 MONTHS."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9897920 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WAS PLANNED REVISION FOR THA (CUP AND HEAD EXCHANGE CASE), BUT PENETRATED THE INNER PLATE OF THE PELVIS DURING IMPACTING THE PSL CUP. SINCE A CEMENT CUP WAS NOT PREPARED, 50G OF -TCP ARTIFICIAL BONE WAS FIXED TO THE DROPPED ACETABULUM WITH TRIDENT HEMISPHERICAL MULCH. THE BOTTOM OF THE CUP WAS IN THE INNER PLATE, FURTHER MORE MANY ARTIFICIAL BONES WERE LEAKED IN THE PELVIS, BUT COMPLETED THE SURGICAL PROCEDURE BY DOCTOR JUDGMENT.

  Patient problems: Injury

  MAUDE report 8921047 ↗
• InjuryJun 4, 2019Osseointegration Problem; Osseointegration Problem

  AT (B)(6) 2015, THA WAS DONE WITH TRIDENT PSL CUP, TRIDENT X3 LINER, NO STRYKER STEM AND DELTA HEAD. AFTER THE OPERATION, THE DOCTOR SUSPECTED LOOSENING OF THE CUP SIDE BY PATIENT SYMPTOMS AND X-P AND CUP SIDE AND HEAD WAS EXCHANGED THE NEW DEVICES. THE BONE RESORPTION AROUND THE CUP AND DISCOLORATION OF THE LINER AND WEAR OF THE LINER WAS CONFIRMED. THE DOCTOR REQUESTED THAT INSPECTION OF WEAR CONDITION OF THE SLIDING SURFACE AND CUP SIDE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8667410 ↗
• InjuryFeb 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  POST-OPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT RETURNED FOR INSTABILITY WITH TWO ANTERIOR DISLOCATIONS. PATIENT WAS REVISED ON (B)(6) 2018. ALL COMPONENTS EXCHANGED EXCEPT FEMUR.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8356613 ↗
• InjuryNov 27, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. THE HEAD, LINER, CONE BODY (IMPLANTED (B)(6) 2017), AND SHELL (IMPLANTED (B)(6) 2012) WERE REVISED. SHELL AND CONE BODY WERE REVISED TO CHANGE PATIENT'S VERSION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8108711 ↗
• InjuryNov 8, 2018Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "LOOSE ACETABULAR SHELL. IMPLANTED NEW SHELL, INSERT AND FEMORAL HEAD".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8053053 ↗
• InjurySep 19, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL. ALL PRIMARY DEVICES EXCEPT THE STEM WERE EXPLANTED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7890177 ↗
• InjuryDec 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  SURGEON REPORTS A PATIENT, POST TOTAL LEFT HIP DONE ON (B)(6) 2016, HAD A RECENT EVENT WHERE SHE SUSTAINED AN ACETABULAR FRACTURE. THE FRACTURE IS NOW HEALED ALTHOUGH THE CUP IS LOOSE AND CAUSING PAIN. SURGEON DECIDED TO REVISE THE CUP AND LINER. THE CUP WAS CAREFULLY REMOVED THE ACETABULUM WAS REAMED AND A TRITANIUM REVISION CUP WAS IMPLANTED WITH SCREWS. SATISFIED WITH THE FIXATION, THE NEW LINER WAS IMPACTED AND A NEW COMPETITOR HEAD WAS IMPLANTED AND THE SURGICAL SITE CLOSED. THE SURGERY WAS PERFORMED WITHOUT INCIDENT.

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

  MAUDE report 7105760 ↗
• InjuryAug 11, 2017Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO A LOOSENED ACETABULAR CUP WHICH HAD FAILED TO IN-GROW INTO PATIENT. SURGEON REPORTED TO COMPANY REPRESENTATIVE THAT THIS HAD NOTHING TO DO WITH THE PRODUCTS BUT CAME ABOUT DUE TO PATIENT'S POOR BONE QUALITY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 6790584 ↗
• MalfunctionAug 7, 2017Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IMPACTION BOLT STUCK IN CUP. THE SURGEON WAS NOT ABLE TO REMOVE THE BOLT FROM THE CUP AS IT GETS COLD WELDED. TO RESOLVE THE SITUATION, THE SURGEON PUT IN A DIFFERENT CUP IN A LARGER SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6771964 ↗
• InjuryJul 27, 2017Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THA WAS DONE WITH TRIDENT HA CUP, X3 LINER, V40 HEAD, CANCELLOUS SCREW, ACCOLADE STEM AND THE PATIENT WAS DISCHARGED THE HOSPITAL 4 WEEKS AFTER OPERATION. A FRACTURE LINE WAS CONFIRMED AT POST OP X-P, HOWEVER, IT WAS NOT CONFIRMED AND THE BONE AROUND SCREW BECAME HOLLOWED OUT AT CURRENT X-P. AFTER DISCHARGED THE HOSPITAL THE PATIENT FELT THE PAIN AT OPERATIVE AREA, WHICH CONTINUED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6749044 ↗