Trident 690-00-28FRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07613327025552), received between Jun 30, 2017 and Apr 23, 2025 — classified as 33 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 30, 2026Open, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3201-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP REVISION. REPLACED WITH STRYKER IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 21892029 ↗
• InjuryFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  CONSTRAINED LINER FAILED. PATIENT WAS REVISED. UPDATE 14-JANUARY-2025: IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO THE INNER BIPOLAR COMPONENT SEPARATING FROM THE OUTER COMPONENT OF THE CONSTRAINED LINER. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP PROVIDED REVISION USAGE AND A PICTURE OF THE EXPLANTS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21345911 ↗
• InjuryNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 18089237 ↗
• InjuryMay 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S HIP WAS REVISED. COMPARING THE USAGE TO THE USAGE FROM A PRIOR REVISION, AN LFIT COCR V40 HEAD AND CONSTRAINED INSERT WERE REVISED TO A 28 +12 LFIT HEAD AND ANOTHER CONSTRAINED INSERT. ADDITIONAL INFORMATION (B)(6) 2023: REASON FOR REVISION: PT FELL DURING A PHYSICAL ACTIVITY AND THE LINER DISENGAGED FROM THE CUP. RIGHT SIDE.

  Patient problems: Fall

  MAUDE report 16852906 ↗
• InjuryMar 22, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: PATIENT HAD SECOND HIP REVISION PROCEDURE IN TWO MONTHS. HER THIRD HIP REVISION PROCEDURE IN TOTAL. ON THIS LATEST OCCASION, HER HIP PROSTHESIS HAD DISLOCATED SIMILAR TO THE PREVIOUS EVENT. SPECIFICALLY, SHE HAD A TRIDENT CONSTRAINED INSERT IN-SITU AND THE BIPOLAR HEAD HAD DISLOCATED FROM THE INSERT THAT IT HAD BEEN PRE-ASSEMBLED IN. THE INSERT WAS STILL IN THE ACETABULAR SHELL BUT THE BIPOLAR HEAD WAS COMPLETELY DISENGAGED FROM IT. THE BIPOLAR HEAD STILL HAD THE FEMORAL HEAD WITHIN IT WHICH ITSELF WAS STILL INTACT ON THE CONE BODY IMPLANT TRUNNION. UPDATE: AS PER INTAKE FORM, THE SURGEON EXPLANTED THE TRIDENT CONSTRAINED LINER, CERAMIC HEAD, TRIDENT CLUSTER SHELL, SCREWS AND THE CONE BODY.

  Patient problems: Joint Dislocation

  MAUDE report 16590148 ↗
• InjuryJan 16, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: THE PATIENT PRESENTED AT THE HOSPITAL ON (B)(4) 2022, HER HIP PROSTHESIS HAD DISLOCATED. SPECIFICALLY, SHE HAD A TRIDENT CONSTRAINED INSERT IN-SITU AND THE BIPOLAR HEAD HAD DISLOCATED FROM THE INSERT THAT IT HAD BEEN PRE-ASSEMBLED IN. THE INSERT WAS STILL IN THE ACETABULAR SHELL, BUT THE BIPOLAR HEAD WAS COMPLETELY DISENGAGED FROM IT. THE BIPOLAR HEAD STILL HAD THE FEMORAL HEAD WITHIN IT, WHICH ITSELF WAS STILL INTACT ON THE CONE BODY IMPLANT TRUNNION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 16173671 ↗
• MalfunctionOct 16, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S RIGHT HIP,, THE CONSTRAINED LINER WAS IMPACTED AND REDUCED. AFTER REDUCTION, THE INNER BIPOLAR PORTION OF THE LINER DISSOCIATED FROM THE OUTER PORTION. THE LINER WAS REMOVED AND ANOTHER LINER OF A DIFFERENT LOT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612885 ↗
• MalfunctionAug 31, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  RIGHT HIP REVISION, CONSTRAINED INSERT FAILED, RELEASING BIPOLAR COMPONENT FROM CAPTURED INSERT. SURGEON HAD TO REVISE STEM, HEAD (STEM AND HEAD REVISED TO COMPETITOR) AND INSERT. UPDATE 10/AUGUST/2022 WG: REP CONFIRMED THIS WAS AN INTRA-OP FAILURE WHICH OCCURRED DURING RIGHT HIP REVISION REPORTED. PER RESPONSE: REMOVAL OF STEM WAS NOT PLANNED DURING REVISION IT WAS REMOVED HOWEVER AS A RESULT OF THE INTRA-OP EVENT. " WHEN THE CONSTRAINED INSERTS FAILED, STEM REMOVAL WAS NECESSARY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327853 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "DISENGAGED CONSTRAINED LINER FROM ACETABULAR CUP WE REPLACED IT WITH ANOTHER 28 HEAD AND F CONSTRAINED LINER. THE PREVIOUS SURGERY FOR THE PATIENT FOR THE SAME ISSUE WAS DONE ON (B)(6) 2022. IMPLANTS AREN'T AVAILABLE AND NO OTHER INFORMATION TO GIVE."

  Patient problems: Insufficient Information

  MAUDE report 15119641 ↗
• MalfunctionJul 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S LEFT HIP, A CONSTRAINED LINER WAS IMPACTED WITH THE CONSTRAINED LINER IMPACTOR. IN FLEXION AND EXTERNAL ROTATION OF APPROXIMATELY 60°, THE INNER BIPOLAR COMPONENT DISSOCIATED FROM THE OUTER LINER. THE CONSTRAINED LINER COMPONENTS AND FEMORAL HEAD WERE REMOVED, AND A 10° CONSTRAINED LINER WAS IMPLANTED WITH ANOTHER FEMORAL HEAD. CAUSE OR CONTRIBUTOR FOR DISSOCIATION WERE UNKNOWN (IMPLANT HAD A LOCKING RING, THERE WERE NO UNUSUAL ANATOMY FACTORS, PROTOCOL WAS FOLLOWED). SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 15-20 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15074326 ↗
• InjuryJul 18, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PATIENT FELL ON HIS HIP.

  Patient problems: Fall

  MAUDE report 15048614 ↗
• InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. A 0° F LINER AND 28 +0 LFIT FEMORAL HEAD WERE REVISED TO ANOTHER 0° F LINER AND 28 +4 LFIT FEMORAL HEAD. UPDATE: "OLD LINER DISASSOCIATED FROM THE SHELL. WE REPLACED IT WITH A NEW LINER AND HEAD. HIP WAS REDUCED AND WAS STABLE AGAIN." UPDATE: ¿CONSTRAINED LINER DISASSOCIATED FROM THE SHELL. HOWEVER, 28MM METAL INNER HEAD WAS STILL CONNECTED TO THE LINER.¿

  Patient problems: Insufficient Information

  MAUDE report 14460581 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12002304 ↗
• InjuryJun 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REMOVED CONSTRAINED LINER THAT THE BIPOLAR CAME OUT OF LINER. REMOVE LINER AND IMPLANTED A NEW CONSTRAINED LINER. UPDATE ON (B)(6) 2021 - BP: REP STATED: "THE INNER BIPOLAR COMPONENT CAME OUT OF THE OUTER (CONSTRAINED) LINER."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11997542 ↗
• InjuryMay 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS PATIENT WAS REVISED AGAIN TODAY (B)(6) 2021. THE PATIENT DISLOCATED THE BIPOLAR HEAD FROM THE CONSTRAINED INSERT. THE STRYKER IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES. UPDATE 19-APRIL-2021 WG: SPOKE TO REP. LEFT HIP. THE (INNER) BIPOLAR COMPONENT OF THE CONSTRAINED LINER DISSOCIATED WITH THE OUTER BEARING OF THE INSERT. THE CONSTRAINED LINER, A SHELL, AND 2 SCREWS WERE REVISED TO COMPETITOR IMPLANTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED SHELL, IT WAS REVISED ONLY TO CONVERT THE PATIENT'S HIP CONSTRUCT. REP PROVIDED USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 11794890 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. A NOTE ON THE REVISION USAGE SHEET STATES "PATIENT UNSTABLE." AS REPORTED BY REP: "PATIENT DISLOCATED. CUP, SCREW, LINER AND HEAD WERE ALL TAKEN OUT." UPDATE 29/SEPTEMBER/2020 WG: SPOKE TO REP. THE SURGEON ORIGINALLY SAID THE PATIENT'S HIP WAS UNSTABLE DUE TO RECURRENT DISLOCATIONS. THE PATIENT DISLOCATED ONCE MORE AND THE SURGEON DECIDED TO REVISE THE SHELL AND SCREW AS WELL AS THE HEAD AND LINER. SHELL WAS REVISED TO CHANGE ITS POSITION, THOUGH THE SURGEON DID NOT REPORT THE SHELL WAS MAL-POSITIONED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10730603 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: BIPOLAR OUTER FEMORAL HEAD WAS LUXATED / DETACHED FROM THE TRIDENT 10 ° CONSTRAINED ACETABULAR INSERT WHILE IN PATIENT. COMPONENTS WERE IMPLANTED IN PATIENT ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 10725214 ↗
• InjuryOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. INTRA-OPERATIVELY, IT WAS NOTED THAT THE OUTER PORTION OF THE CONSTRAINED LINER HAD CRACKED AND THE BIPOLAR INSERT WAS COMING OUT OF THE CRACK. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED (THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD). THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9155931 ↗
• InjurySep 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED THEIR CONSTRAINED LINER FROM THE CUP AGAIN ON (B)(6) 2019. ON (B)(6) 2019, LINER WAS REVISED TO A CONSTRAINED LINER, TRIDENT CONSTRAINED ACETABULAR INSERT, SIZE F, REF CODE: 690-00-28F, LOT: LW556T. PATIENT HAS TERTIARY SYPHILIS. THIS HAS MANIFESTED IN THE FOLLOWING WAYS ACCORDING TO THE TREATING MEDICAL TEAM, LOSS OF MUSCULAR CONTROL AND INHIBITION FOR NEUROLOGICAL FUNCTION. IS UNABLE TO UNDERSTAND OR FOLLOW DIRECTIONS AND DAILY PUTS THEIR HIPS IN EXTREME RANGES OF MOTION, AS A CONSEQUENCE OF THEIR CONDITION. THIS PATIENT'S ORIGINAL SURGERY WAS ON (B)(6) 2019 AND IT WAS FIRST REVISED ON (B)(6) 2019 FOR DISLOCATION. PATIENT REVISED AGAIN (B)(6) 2019 AFTER A DISASSOCIATION OF A CONSTRAINED LINER ON (B)(6) 2019.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9123639 ↗
• InjurySep 24, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Insufficient Device Problem Information; Detachment of Device or Device Component; Device Dislodged or Dislocated; Insufficient Device Problem Information

  BIPOLAR PORTION DISLOCATED DESPITE APPROPRIATE IMPLANT POSITIONING WITH A SIMPLE TWIST AND FALL. BIPOLAR PORTION SEPARATED FROM HEAD SUBSEQUENTLY IN THE TISSUES. RESIDUAL LINER CAME OUT TOO EASILY FROM THE TRIDENT SHELL.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation

  MAUDE report 9109354 ↗
• InjuryAug 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER THE SURGERY ON THE (B)(6) 2019, PATIENT DISLOCATED AGAIN. THIS PI IS FOR THE REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2019 WHEREBY THE "CONSTRAINED LINER WAS REVISED TO PUT A LONGER HEAD ON".

  Patient problems: Injury

  MAUDE report 8861267 ↗
• InjuryJul 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT THE TRIDENT CONSTRAINED CUP (RIGHT SIDE) DISLOCATED INTERNALLY AFTER A MONTH IN SITU. THE DEVICE WAS A TRIDENT MULTIHOLE IN SITU WITH 2 X SCREWS. EXETER STEM IN SITU WITH 28 -4 HEAD. STEM AND UNCEMENTED CUP WELL FIXED NO KNOWN TRAUMA ¿ PATIENT APPEARS TO BE CONFUSED. THE SURGEON HAD TO USE DRILL BITS, THE REMOVAL TOOL, SCREWS AND FINALLY TO IMPACT THE REMOVAL TOOL INTO THE POLY RIM TO FINALLY EXTRACT THE OUTER PART OF THE CONSTRAINED WHICH WAS STILL WELL FIXED INTO THE INNER-CHANGE LOCKING MECHANISM OF THE TRIDENT MULTIHOLE.

  Patient problems: Injury

  MAUDE report 8840906 ↗
• InjuryJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE CONSTRAINED LINER FROM THE ACETABULAR SHELL. REP PROVIDED PRE-REVISION X-RAYS, PICTURES OF THE EXPLANTS, AND AN IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON. THIS PI IS FOR REVISION 2.

  Patient problems: Injury

  MAUDE report 8738100 ↗
• InjuryJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISSOCIATION OF IMPLANTED TRIDENT CONSTRAINED LINER (THE LARGE HEAD FROM INSERT) DURING ACETABULAR RANGE OF MOTION TESTING - REVISION HIP SURGERY (B)(6) 2019, REFERENCE NUMBER 690-00-28F. DISSOCIATED IMPLANT COMPONENTS REASSEMBLED AND RETRIALED WITH THE SURGEON REPORTING SATISFACTORY STABILITY. ORIGINAL PRIMARY HIP REPLACEMENT (B)(6) 2019. EXETER TRIDENT. REVISION TO A CONSTRAINED LINER FOR RECURRENT DISLOCATION X3. UPDATE 05/JUNE/2019 (B)(6): SURGICAL DELAY INDICATED AS YES.

  Patient problems: Injury

  MAUDE report 8734509 ↗
• InjuryJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A DISLOCATED HIP AND REQUIRED REVISION. ON OPENING THE PATIENT, IT WAS CONFIRMED THAT THE TRIDENT F CONSTRAINED LINER HAD DISASSOCIATED. THE BIPOLAR HEAD HAD PULLED OUT OF THE F INSERT WHICH REMAINED LOCKED INTO THE TRIDENT SHELL. THE BIPOLAR PART OF THE CONSTRAINED LINER AND THE 28MM HEAD RENAISSANCE REMAINED IN THE TRUNION OF THE LIMA STEM. ( NB. THE 28MM HEAD WAS A LIMA PRODUCT).

  Patient problems: Injury

  MAUDE report 8687196 ↗