Trident 623-00-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 07613327039542), received between Mar 7, 2017 and Apr 22, 2026 — classified as 103 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (54 reports).

2 other recalls cover devices cleared under the same FDA submission (K033716); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. A HEAD, LINER, AND 2 SCREWS WERE REMOVED AND A HEAD AND LINER WERE IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 24958640 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS PI IS FOR THE RIGHT HIP. AS REPORTED: I RECEIVED A TOTAL HIP OF BOTH HIPS, THE FIRST, IN 2015 (R) AND 2017 (L). VIBRATIONS STARTED IN 2018. UPON INVESTIGATION OF THE FREQUENCIES, I LEARNED A BLE (BLUETOOTH LOW ENERGY) READING IDENTIFYING THE UUID (UNIVERSALLY UNIQUE IDENTIFIER) OF COMPETITOR MICROCHIP IS BEING EMITTED. PLEASE HELP ME IDENTIFY IF THE PARTS MAY HAVE BEEN FITTED WITH AFTERMARKET DEVICES. IT'S NOT ONLY ANNOYING BUT IT'S BECOMING PAINFUL.

  Patient problems: Pain

  MAUDE report 22050942 ↗
• InjuryFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF PRIMARY HIP SURGERY. PAIN AND DISLOCATION. DISCOLORED TISSUE INTRA-OPERATIVE. RIGHT SIDE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21468591 ↗
• InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT ON (B)(6) 2018 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE PER ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD A DISLOCATION OF THE LEFT HIP ON (B)(6) 2021 AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. INTRAOPERATIVELY, "CORROSION" WAS FOUND AT THE METAL TRUNNION. IT IS NOT REPORTED WHAT OTHER DEVICES BESIDES THE METAL HEAD WERE REVISED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 20558654 ↗
• InjurySep 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. A CERAMIC HEAD AND POLY LINER WERE REVISED TO A METAL MDM LINER, ADM/ MDM POLY INSERT, AND METAL FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 20272179 ↗
• InjuryMay 30, 2024Degraded; Naturally Worn; Degraded; Naturally Worn

  SURGEON CALLED ME AFTER A REVISION OF AN ACCOLADE TMZF STEM. THE SURGEON SAID THAT STEM/HEAD HAS ALMOST AN IDENTICAL ISSUE AS ANOTHER REVISION HE DID IN FEBRUARY. HE SAID THAT THE STEM TRUNNION IS WORN AND DAMAGED AND SO IS THE HEAD. THERE IS POLY BACKSIDE WEAR, WHERE IT LOOKS LIKE A THIN FILM OF PLASTIC HAS DELAMINATED FROM THE BACK OF THE LINER. HE SAID THE LINER IS WORN BUT NOT FAILED. HE SAID THE PATIENT HAS HAD 4-5MONTHS OF PAIN IN THE HIP, UNKNOWN ORIGIN, THEY TWISTED IN THE KITCHEN THE WEEK BEFORE, AND SUDDENLY COULDN'T WEIGHT BEAR ANYMORE. THERE WAS LOTS OF METALLOSIS IN THE PATIENT. I WILL ADD MORE NOTES TO THIS AFTER GETTING MORE DETAILS FROM THE SURGEON IN THE COMING DAYS. POSTERIOR APPROACH, LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19424534 ↗
• InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. INITIAL REASON FOR REVISION WAS FLUID BUILDUP IN THE HIP. INTRA-OPERATIVELY, THE SURGEON FOUND WHEN PUTTING THE HIP THROUGH ROM THAT THE HEAD WAS PARTIALLY DISLOCATING OUT OF THE LINER. A POLY INSERT AND CERAMIC HEAD WERE REVISED TO A CONSTRAINED INSERT AND LFIT METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18824583 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2014, AND WAS REVISED ON (B)(6) 2023. IT IS FURTHER ALLEGED THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE: PER MEDICAL RECORDS RECEIVED, THE REVISION OPERATIVE REPORT STATES THIS THA HAD DISLOCATED MULTIPLE TIMES NECESSITATING REVISION. INTRA-OPERATIVELY A GREAT DEAL OF METALLIC DEBRIS WAS ENCOUNTERED AS WELL AS A LARGE EFFUSION. UPON REMOVAL OF THE V-40 FEMORAL HEAD THE SURGEON REMARKED THE "TRUNNION WAS INTACT". COMPONENTS WERE "WELL FIXED". THE LINER WAS EXCHANGED TO ONE WITH AN ELEVATED RIM. A SLEEVE AND NEW HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 18473782 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT SUFFERED A 3RD EPISODE OF LEFT THP DISLOCATION DURING THE NIGHT OF (B)(6) 2022 WHILE GETTING UP FROM THE TOILET. REDUCTION SURGERY USING EXTERNAL MANEUVERS WAS PERFORMED UNDER GENERAL SEDATION ON (B)(6) 2022.

  Patient problems: Joint Dislocation

  MAUDE report 16875690 ↗
• InjuryMay 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD TWO DISLOCATIONS. THE SECOND DISLOCATION, OCCURRING ON (B)(6) 2022, WAS TREATED BY "REDUCTION BY EXTERNAL MANEUVERS UNDER GENERAL ANESTHESIA."

  Patient problems: Joint Dislocation

  MAUDE report 16866087 ↗
• InjuryMar 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (PHARMACIST) REPORTED THAT 'I AM SENDING YOU THIS E-MAIL TO INFORM YOU OF A PATIENT'S RE-INTERVENTION FOLLOWING REPEATED DISLOCATIONS WITH ONE OF YOUR THPS INSTALLED 12 YEARS AGO.'

  Patient problems: Joint Dislocation

  MAUDE report 16653798 ↗
• InjuryDec 20, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  AS REPORTED: "HEAD & LINER WERE EXCHANGED DURING AN IRRIGATION AND DEBRIDEMENT MEANT FOR INFECTION. STRIPE WEAR PRESENT ON CERAMIC & LINER. SURGEON REPORTED CORROSION PRESENT ON NECK/TRUNNION OF FEMORAL STEM".

  Patient problems: Unspecified Infection

  MAUDE report 16013362 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN ACUTE POSTOPERATIVE INFECTION, FOR WHICH THE PROCEDURE OF DAIR HAS BEEN OPTED FOR PRACTICING EXTENSIVE SURGICAL CLEANING OF THE JOINT AND REPLACEMENT OF MOVING COMPONENTS. THE INTERVENTION WAS PERFORMED ON (B)(6) 2022. REASON FOR WHICH THE DEVICE WAS USED: LEFT HIP TOTAL PROSTHESIS IMPLANT IN SECONDARY COXARTHROSIS.

  Patient problems: Unspecified Infection

  MAUDE report 15467177 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PRIMARY SURGERY IN 2013 AND HAS BEEN HAVING "PAIN IN GROIN" AND "PROBLEM LIFTING LEG". PATIENT HAS HAD SEVERAL TESTING DONE AND NOTED X-RAYS SHOWS IMPLANTS "IN PLACE" AND MRI RESULTS WERE "SKEWED DUE TO THE METAL". PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15400294 ↗
• InjuryAug 22, 2022Adverse 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 INFECTION. ALL COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 15272065 ↗
• InjuryMay 26, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON (B)(6) 2008. IT IS ALLEGED THAT THE PATIENT RECEIVED A LETTER FROM UPMC ON AUGUST 28, 2018 INFORMING HIM OF THE VOLUNTARY RECALL FOR POTENTIAL DEFECTS OF SAID IMPLANTS AND THAT HE SHOULD COME IN FOR TESTING. HE HAS BEEN REVISED ON UNKNOWN DATE. THIS IS FOR THE RIGHT HIP. REVISION ON RIGHT HIP TOOK PLACE ON (B)(6) 2019. UPDATE ON 04-MAY-2022 PER CLINICIAN REVIEW: "IN THE OPERATIVE REPORT FOR THE RIGHT HIP THE SURGEON NOTES THAT THE PATIENT WAS COMPLETELY ASYMPTOMATIC BUT WANTED THE COCR HEAD EXCHANGED DUE TO THE RECALL. DURING THE SURGERY ACETABULAR LINER WEAR WAS NOTED AND ALONG WITH THE HEAD EXCHANGE THE WORN LINER WAS REMOVED AND A NEW LINER IMPLANTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517520 ↗
• InjuryMay 16, 2022Adverse 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 LINER AND FEMORAL HEAD WERE EXCHANGED FOR ANOTHER LINER, CERAMIC HEAD AND SLEEVE.

  Patient problems: Unspecified Infection

  MAUDE report 14404588 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS UNDER INFECTION AFTER TOTAL HIP ARTHROPLASTY. THE OPERATION DATE WAS (B)(6) 2021 AND HE VISITED THE HOSPITAL AGAIN WITH INFECTION TWO MONTHS LATER. LEFT LEG. PRODUCT: STEM(ACCOLADE II),HEAD(V40 CERAMIC),INSERT(X3 POLY INSERT),CUP(TRIDENT II TRITANIUM CLUSTER) UPDATE: DAIR (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) WAS PERFORMED 6 WEEKS POST-PRIMARY OPERATION AND DISCOVERED MSSA. IMPLANTS WERE NOT REMOVED DURING THIS PROCEDURE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 13768173 ↗
• InjuryMar 1, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT HAD LEFT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH INSTABILITY. UNDERGOES REVISION ON (B)(6) 2021. ONLY HEAD AND LINER ARE EXCHANGED.

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

  MAUDE report 13630266 ↗
• InjuryOct 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "RIGHT HIP WAS REVISED TO A 2 STAGE SPACER FOR INFECTION. ALL COMPONENTS WERE REMOVED. THIS IS THE FIRST REVISION OF THIS HIP. ALL INFORMATION ON THIS PATIENT IS INCLUDED IN THIS REPORT." REP PROVIDED THE PRIMARY USAGE SHEET.

  Patient problems: Unspecified Infection

  MAUDE report 12704175 ↗
• InjuryOct 21, 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 IN A STAGE 1 REVISION FOR INFECTION. A SIZE 3 ACCOLADE II STEM, 36 -5MM CERAMIC V40 HEAD, 52E TRIDENT SHELL, 36E TRIDENT X3 INSERT, AND 1 SCREW WERE EXPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12671762 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "LEFT HIP. REVISED HEAD AND LINER DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." REP PROVIDED PRIMARY AND REVISION USAGE AND AN X-RAY.

  Patient problems: Unspecified Infection

  MAUDE report 12572912 ↗
• InjuryOct 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY USAGE SHEET AND NOTES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12568816 ↗
• InjurySep 9, 2021Naturally Worn; Naturally Worn

  IT HAS BEEN REPORTED "REVISION SURGERY OF A PATIENT WAS SCHEDULED. THIS PATIENT RECEIVED A STRYKER HIP IMPLANT 6 MONTHS AGO. AN ACCOLADE STEM AND A TRIDENT II CUP. REASON FOR REVISION WAS PAIN. TREATMENT: REMOVING THE OLD LINER AND HEAD AND PUT IN A NEW HEAD AND LINER. UPON REMOVING THE ¿OLD¿ LINER, THE SURGEON NOTICED A ¿YELLOWISH¿ DISCOLOURING OF THE LINER.

  Patient problems: Pain

  MAUDE report 12446421 ↗
• InjuryAug 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT IS A (B)(6)-YEAR-OLD FEMALE WHO UNDERWENT RIGHT TOTAL HIP REPLACEMENT. PATIENT HAD WOUND DRAINAGE AND UNDERWENT REVISION IN (B)(6) 2020. POLYETHYLENE AND HEAD COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12323562 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033716. One submission often covers many models, so check the product and lot details in each record.

• Z-2810-2015 · Jun 25, 2015 · Terminated
  Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
• Z-0909-2010 · Feb 17, 2006 · Terminated
  Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to