Trident 690-00-22ERecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07613327025545), received between Mar 9, 2017 and Oct 4, 2024 — classified as 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISED A RIGHT HIP CONSTRAINED LINER TO AN MDM DUE TO CONSTRAINED LINER DISENGAGING FROM THE CUP. ORIGINAL REVISION TO CUP AND MDM ON (B)(6) 2017. 2ND REVISION TO CONSTRAINED LINER WAS DONE AT THE SAME HOSPITAL AND SURGEON ON (B)(6) 2020. THE STEM NECK SHOWED WEAR FROM RUBBING ON THE CONSTRAINED LINER RIM.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20368310 ↗
• InjuryMay 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP REVISION. THE CONSTRAINED LINER DISASSOCIATED FROM THE SHELL. CHANGED THE CONSTRAINED POLY AND HEAD. WENT UP TO +3 HEAD. POLY AND HEAD THAT CAME OUT WERE FINE/NO TRAUMA TO THEM.

  Patient problems: Joint Dislocation

  MAUDE report 19389553 ↗
• InjuryFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION RTHA- DISSOCIATED CONSTRAINED LINER FROM CUP. REVISING TO ANOTHER CONSTRAINED LINER AND CHANGING THE PROXIMAL FEMUR COMPONENT STANDARD TO ANTEVERTED COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 18809585 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. THE CONSTRAINED LINER, HEAD AND REST MOD PROXIMAL BODY WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REASON FOR REVISING WAS NOT GIVEN TO REP WHEN HOSPITAL STAFF WAS ASKED (NEITHER WERE ANY ALLEGATIONS MADE OR OBSERVED).

  Patient problems: Joint Dislocation

  MAUDE report 18717798 ↗
• InjuryDec 21, 2023Noise, Audible; Noise, Audible

  PATIENT REPORTED CLICKING IN HIP JOINT ON MOVEMENT AFTER REVISION OF LEFT TR TO CONSTRAINED LINER FOR RECURRENT DISLOCATION.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18379017 ↗
• InjuryNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER (INNER BIPOLAR COMPONENT DISSOCIATED FROM THE OUTER COMPONENT).

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18054062 ↗
• InjuryJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION. THE CONSTRAINED LINER HAD COME OUT OF THE SHELL, AND THE INNER BIPOLAR PORTION OF THE CONSTRAINED LINER CAME OUT OF THE OUTER LINER. THE HEAD AND CONSTRAINED LINER WERE REVISED. THE HEAD AND LINER AND ONE SCREW WERE REMOVED, AND A NEW HEAD AND LINER WERE IMPLANTED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE WASTED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 17386705 ↗
• InjuryDec 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISED A LINER AND HEAD ON A RIGHT HIP DUE TO THE CONSTRAINED LINER DISENGAGING FROM THE SHELL. HE CONVERTED TO MDM. THE FIRST REVISION WAS ON (B)(6) 2022 DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 15940110 ↗
• InjuryOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DISLOCATED HIP, FOLLOWING A REVISION OF THE SAME HIP ON (B)(6) 2022. HEAD/LINER EXCHANGE, ALONG WITH AN EXTENSIVE I&D, AND TISSUE REARRANGEMENT TO HELP WITH THE PT'S HIP-STABILITY. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO." SPOKE TO REP. THE CONSTRAINED LINER DISSOCIATED OUT OF THE SHELL. THE CONSTRAINED INSERT AND 22.2 +0 FEMORAL HEAD (IMPLANTED (B)(6) 2022) WERE REVISED TO ANOTHER CONSTRAINED INSERT AND FEMORAL HEAD (SAME CATALOG NUMBERS). THE SHELL (IMPLANTED (B)(6) 2020) WAS NOT REVISED. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15624169 ↗
• MalfunctionNov 23, 2021Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  DURING A THR WHEN DISLOCATING THE HIP THE CONSTRAINT LINER PULLED APART. SURGERY FOR TUMOUR IN PROXIMAL RIGHT FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861596 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE ACETABULAR SHELL. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED. REP PROVIDED USAGE SHEET FROM THE PRIMARY STRYKER IMPLANTATION AND FOLLOWING REVISIONS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12363699 ↗
• InjuryJun 23, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED AFTER A FAILED CLOSED REDUCTION. INTRA-OPERATIVELY, THE INNER BIPOLAR COMPONENT OF THE CONSTRAINED LINER WAS FOUND TO BE DISSOCIATED FROM THE OUTER LINER. THE LINER AND COMPETITOR HEAD WERE REVISED TO A NEW CONSTRAINED LINER, COMPETITOR HEAD, AND A BRACE WAS APPLIED. REP REPORTED THAT THE EXPLANT IS AVAILABLE FOR RETURN AND THAT HE CAN PROVIDE PICTURES AND USAGE FOR THE PRIOR SURGERY. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OPERATING ROOM SURGEON.

  Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048555 ↗
• InjuryMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE ACETABULAR SHELL. THE LINER AND FEMORAL HEAD WERE REVISED TO AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND ANOTHER FEMORAL HEAD. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11557829 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A 22.2 +3 LFIT HEAD AND TRIDENT 0° E CONSTRAINED INSERT WERE SWAPPED FOR DEVICES OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 11121190 ↗
• InjuryDec 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER (IMPLANTED (B)(6) 2019) FROM THE SHELL (IMPLANTED (B)(6) 2018). SURGEON REPORTED CONTRIBUTING PATIENT FACTOR OF DEMENTIA. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED TO THE SAME CATALOG NUMBERS. REP PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 10940515 ↗
• InjuryNov 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. SURGEON REPORTED THAT DUE TO IMPINGEMENT WITH THE STEM, THE LINER WAS LEVERED OUT OF THE SHELL. ALSO, THE SHELL WAS IN A NEUTRAL POSITION. A SHELL AND 2 SCREWS (IMPLANTED IN 2011), RESTORATION MODULAR PROXIMAL BODY (IMPLANTED IN 2013), LFIT FEMORAL HEAD AND CONSTRAINED LINER (BOTH IMPLANTED IN 2019) WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10841563 ↗
• InjuryOct 27, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PATIENT HAS A TRIDENT CONSTRAINED LINER 690-00-22E THAT HAS GONE IN TO LUXATION. THE 36MM INNER HEAD HAS 'POPPED' OUT OF THE OUTER POLY-PART. THE LOCKING RING IS INTACT. PATIENT. WILL GET A NEW OPERATION TODAY. UPDATE: "THE PATIENT IS A 75 YEAR OLD WOMAN. APART FROM ARTHROSIS IN THE LEFT HIP SHE IS WITHOUT PRE-EXISTING CONDITIONS. SHE HAS NORMAL BMI AND IS EXTREMELY ACTIVE. SHE WAS OPERATED (B)(6) 2020 WITH A PRIMARY THA UNCEMENTED (TRIDENT/CORAIL). THE CUP WAS ANTEVERTED ONLY ABOUT 5-7 DEGREES. NORMAL POSITION OF THE STEM. SHE SUSTAINED 3 DISLOCATIONS OF THE LEFT HIP AND WAS RE-OPERATED (B)(6) 2020 CHANGING THE STANDARD 10 DEGREE LINER TO A CONSTRAINED LINER. IN ASSOCIATION WITH FORCED FLEXION THE HIP DISLOCATED (B)(6) 2020. THE 28MM HEAD WAS SEPARATED FROM THE POLY-LINER WHICH WAS STILL SITUATED IN THE CUP. THE LOCKING RING WAS STILL IN PLACE. DURING RE-OPERATION (B)(6) I DISCOVERED THAT THE LOCKING-RING HAS WIDENED PRESUMABLY CAUSED BY COLLISION BETWEEN THE NECK OF THE STEM AND THE RIM OF THE POLYETHYLENE. THE SOLUTION WAS A CEMENTED CONSTRAINED LINER IN THE EXISTING CUP IN CORRECT ANTEVERSION. THERE SEEMS TO BE A PROBLEM WITH THE TRIDENT CONSTRAINED LINER BEING THAT THE LOCKING

  Patient problems: Joint Dislocation

  MAUDE report 10740217 ↗
• InjuryOct 21, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED BY REP: DR. REVISED A GMRS TOTAL FEMUR DUE TO A DISASSOCIATED TRIDENT CONSTRAINED LINER. THE METAL BIPOLAR COMPONENT DISASSOCIATED FROM THE POLY LINER" A CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED. RIGHT HIP. "THE METAL BIPOLAR COMPONENT DISLOCATED FROM THE POLY LINER, THE V40 HEAD DID NOT DISLOCATE FROM THE METAL BIPOLAR COMPONENT."

  Patient problems: Joint Dislocation

  MAUDE report 10709971 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT HIP REVISION FOR PAIN AND PROFUSION IN JOINT. CONSTRAINED INSERT REVISED TO MDM.

  Patient problems: Discomfort; Pain

  MAUDE report 10610684 ↗
• InjuryDec 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A 6TH REVISION OF HER RIGHT HIP DUE TO DISLOCATION (SEE CROSS REFERENCES FOR ALL PREVIOUS REVISIONS) ON (B)(6) 2019. REP WAS NOT MADE AWARE OF WHICH DEVICE(S) DISLOCATED OR DISASSOCIATED. THE SURGEON CANNOT OFFER ANY EXPLANATION AS TO THE POSSIBLE CAUSE OR CONTRIBUTOR TO DISLOCATION AS EVERY TIME THE PATIENT IS REVISED, AN EXTREME ROM IS TESTED SUCCESSFULLY PRIOR TO SURGERY COMPLETION. THE ACETABULAR SHELL AND TWO SCREWS (IMPLANTED (B)(6) 2019), LINER AND FEMORAL HEAD (BOTH IMPLANTED (B)(6) /2019) WERE REVISED TO A NEW FEMORAL HEAD AND BIPOLAR CONSTRUCT WITH THE EXPECTATION THAT FURTHER DISLOCATIONS WILL BE BETTER MANAGED. REP WILL TRY TO PROVIDE THE REVISION USAGE DATA, MAY BE ABLE TO PROVIDE DISLOCATION DETAILS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 22/JANUARY/2020 WG: REP CONFIRMED THAT REVISION DID TAKE PLACE ON (B)(6) 2019. THE REP WAS UNABLE TO DISCOVER WHICH DEVICE(S) DISLOCATED OR DISASSOCIATED FROM EACH OTHER. REP PROVIDED THE REVISION USAGE SHEET AND RE- CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9452558 ↗
• InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: PRIMARY OUTSIDE CORS SCOPE. THE PATIENT UNDERWENT RIGHT HIP REVISION (B)(6) 2019. PATIENT HAD PERIPROSTHETIC JOINT INFECTION THEN UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY, ALL COMPONENTS EXCHANGED EXCEPT CUP IN (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9202379 ↗
• InjuryOct 17, 2019Unstable; Unstable

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019. PROCEDURE: THE PATIENT HAD RIGHT TOTAL HIP REPLACEMENT OUTSIDE HOSPITAL (B)(6) 2011. AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018. BECAUSE OF EXTENSIVE SOFT TISSUE DESTRUCTION THAT LED PATIENT PRESENTING SYMPTOM OF INSTABILITY, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION LINER, HEAD, AND PROXIMAL RMS (BODY) COMPONENTS EXCHANGED ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9202377 ↗
• InjurySep 27, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CONSTRAINED LINER REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THE PATIENT COMPLAINED OF PAIN AND X-RAY SHOWED THE LEFT SIDE CONSTRAINED LINER WAS DISLOCATED IN A PATIENT BODY. WHEN THE SALES REP CHECKED REMOVED PRODUCT FROM THE PATIENT'S BODY, HEAD AND LINER WERE SEPARATED. THE CONSTRAINED LINER WAS REVISED SUCCESSFULLY.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 9130856 ↗
• InjuryAug 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISASSOCIATION OF THE BIPOLAR HEAD FROM THE OUTER INSERT OF A CONSTRAINED LINER. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED (REP REPORTED THERE WERE NO ALLEGATIONS AGAINST FEMORAL HEAD). REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.`

  Patient problems: Injury

  MAUDE report 8920701 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REPORTS PATIENT HAD A RIGHT REVISION HIP, LINER/HEAD EXCHANGE PERFORMED ON (B)(6) 2019 IS NOW DRAINING AND HE WOULD LIKE TO WASH OUT THE SURGICAL SITE AND RE IMPLANT A NEW LINER AND HEAD. HE NOTED THAT THE DRAINAGE LOOKED AS IF IT WAS METALLIC IN COLOR. THE WASHOUT AND EXCHANGE WAS PERFORMED WITHOUT INCIDENT. NO MORE INFORMATION AVAILABLE DUE TO PASSWORD SECURED EMR.

  Patient problems: Injury

  MAUDE report 8752353 ↗