Trident 502-11-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540432032), received between Jun 9, 2017 and Aug 25, 2023 — classified as 15 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 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 25, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN, INSTABILITY, AND TRUNNIONOSIS. SURGEON REPORTED VIA PRE-REVISION X-RAY THAT THE CUP HAD TOO MUCH ANTEVERSION. INTRA-OPERATIVELY, THE HEAD WAS FOUND TO BE 'A LITTLE LOOSE' ON THE TRUNNION. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A NEW HEAD, LINER AND SHELL. WHILE REAMING FOR THE NEW SHELL, THE PATIENT'S FEMORAL ARTERY WAS SEVERED. A VASCULAR SURGEON WAS BROUGHT IN TO ADDRESS THE ISSUE AND PERFORM A BYPASS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 3 HOURS. THE PATIENT WAS EVENTUALLY PRONOUNCED STABLE AFTER HAVING GONE TO THE ICU. REP CONFIRMED THAT NO STRYKER IMPLANTS OR INSTRUMENTS CONTRIBUTED TO THE SEVERING OF THE ARTERY, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 17622365 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LETTER WAS RECEIVED FROM A PATIENT. THE PATIENT REPORTED THAT SHE HAD BEEN IMPLANTED WITH A STRYKER HIP IMPLANT. THE PATIENT FURTHER REPORTED THAT HER MEDICAL RECORDS INDICATED THAT HER FEMUR WAS NARROW AND ALSO THAT SHE WAS REAMED WITH A SIZE 51 REAMER. THE PATIENT REPORTED PAIN DURING EXERCISE SINCE (B)(6) 2016. NO PAIN AT REST. ALL MUSCLES ON THE RIGHT SIDE ARE SORE.

  Patient problems: Discomfort; Inflammation; Osteolysis; Pain

  MAUDE report 12677719 ↗
• InjuryFeb 25, 2021Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  2014 RIGHT HIP REPLACEMENT WITH STRYKER, 2017 LEFT HIP REPLACEMENT WITH STRYKER. UPDATE: AS PER PATIENT, SHE HAD A RIGHT THA DONE (B)(6) 2013 ABOUT FOUR MONTHS AFTER SURGERY SHE COULDN'T WALK DURING PT, SHE STARTED TO EXPERIENCE PAIN, HAS NO BALANCE. PATIENT HAS TO USE A WALKER. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF A RECALL. PATIENT IS SEEKING ASSISTANCE WITH REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Anemia; Depression; Joint Laxity; Pain

  MAUDE report 11378364 ↗
• InjuryJul 17, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED, AS THE SURGEON REPORTED THAT THE SHELL WAS IN POOR POSITION. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10288222 ↗
• InjuryFeb 21, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED BY REP: "LOOSE ACETABULAR SHELL". THE SHELL, HEAD AND LINER WERE REVISED. UPDATE PER RESPONSE: "THERE ARE NO ALLEGATIONS FROM SURGEON AGAINST THE 2 IMPLANTS QUESTIONED" (REVISED LINER AND REVISED FEMORAL HEAD).

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9739323 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  2ND DISLOCATION OF PATIENTS HIP.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9513202 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  1ST DISLOCATION OF PATIENTS HIP.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9512978 ↗
• MalfunctionNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR COMMENTED THAT ON POST OP X-RAY THE MDM LINER DIDN¿T LOOK SEATED IN TRIDENT CUP ALTHOUGH AT TIME OF OPERATION IT WAS SOLID & APPEARED TO BE SOLID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9351227 ↗
• InjuryOct 2, 2019Osseointegration Problem; Osseointegration Problem

  REVISION OF RIGHT TOTAL HIP. LOOSENING OF ACETABULAR SHELL DUE TO POOR BONE DISCOVERED ON FOLLOW UP X-RAY AT 6 MONTH. CEMENTED EXETER RIMFIT CUP INSERTED. ORIGINAL SURGERY (B)(6) 2019. THIS IS ALL THE INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9145847 ↗
• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY SALE REPRESENTATIVE THAT DURING HIP SURGERY, TRIDENT CUP WAS FAILED TO FIX AFTER UNDER REAMING ACCORDING TO SURGICAL TECHNIQUES. SURGEON TRIED TO IMPACT CUP BUT STILL LOOSE. THE HIP ACETABULUM WAS BROKEN AND THEN CHANGED TO USE CEMENTED CUP. THE OPERATION WAS COMPLETED SUCCESSFULLY. UPDATE: PRIMARY PROCEDURE, THE ACETABULUM BROKE DURING IMPACTION, NOT STRONG BOND QUALITY. SURGICAL DELAY: 20-30 MIN, RIGHT SIDE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9006304 ↗
• InjuryAug 27, 2019Mechanical Problem; Mechanical Problem

  THE SURGEON REPORTED TO THE REP THAT A REVIEW OF X-RAYS TAKEN IMMEDIATELY POST-OPERATIVELY FOR A PRIMARY LEFT THA SHOW THE MDM LINER WAS NOT LOCKED INTO THE SHELL. THE SURGEON PLANS TO MONITOR THE PATIENT BUT DOES NOT HAVE ANY PLAN TO REVISE THE PATIENT AT THE TIME OF REPORT. THE REP PROVIDED THE POST-OP X-RAYS AND USAGE SHEET. THE REP REPORTED HE MAY BE ABLE TO GET THE OPERATIVE REPORT, AND THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8934924 ↗
• InjuryApr 26, 2019Osseointegration Problem; Osseointegration Problem

  THE SURGEON REPORTED THAT HE UNDERTOOK A REVISION OF PATIENT WHO HAD BEEN IMPLANTED WITH AN MDM LINER AND TRIDENT ACCOLADE COMBINATION. THE REVISION WAS DUE TO PAIN. THE SURGEON REPORTED THAT THE MDM LINER WAS WELL FIXED AND THAT WHEN THE SCREWS WERE REMOVED THE SHELL CAME OUT. THERE WAS NO BOND BETWEEN THE BONE AND SHELL. THE SURGEON FURTHER REPORTED ALVAL AND BONE LOSS WHICH HE GRADED AS 2C. THE BONE HAD THE APPEARANCE OF COTTAGE CHEESE. THERE HAD BEEN EVIDENCE OF OSSEOINTEGRATION ON THE SHELL WHICH HAD SUBSEQUENTLY DE-BONDED. THE PATIENT REQUIRED 2 SACHETS OF BONE CHIPS AS A GRAFT AND AN ALTERNATIVE CUP WAS USED TO COMPLETE THE REVISION. THE SURGEON FURTHER REPORTED THAT THE PATIENT HAD ORIGINALLY PRESENTED ON (B)(6) 2018 WITH PAIN AND ASPIRATES DID NOT INDICATE INFECTION (CRP WAS 2 AND ESR WAS 8). ADDITIONALLY SAMPLES TAKEN DURING THE REVISION TESTED NEGATIVE FOR GROWTH.

  Patient problems: Inadequate Osseointegration; Injury; Osteolysis; Pain

  MAUDE report 8557657 ↗
• InjuryFeb 12, 2019Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A HIP REVISION. UPDATE; PER RECEIVED IMAGES, IT APPEARS THE TRUNNION IS WORN AND HEAD DISLOCATED. UPDATE: AS PER MEDICAL REVIEW CONCLUSION: CUP MALPOSITION IN LOW INCLINATION WITH ADDITIONAL INAPPROPRIATE USE OF A 10° CUP LINER IN A CUP SHELL WITH ALREADY LOW INCLINATION HAS CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY LEADING TO EXCESSIVE CORROSION IN THE TAPER JUNCTION WITH GRADUAL LOSS OF TAPER LOCK FUNCTIONALITY AND ULTIMATELY DISASSOCIATION BETWEEN FEMORAL HEAD AND TRUNNION REQUIRING REVISION SURGERY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8331633 ↗
• InjuryOct 25, 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 CALLED STATING HE HAD A LEFT THA ON OR ABOUT (B)(6) 2015. PATIENT HAS BEEN IN CONSTANT PAIN SINCE SURGERY. PATIENT SAYS IT FEELS LIKE METAL IS RUBBING ON HIS MUSCLES. LOTS OF PRESSURE IN THE HIP AREA.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 6977723 ↗
• InjuryAug 18, 2017Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 2017. THE PATIENT SUBSEQUENTLY HAD MULTIPLE DISLOCATIONS. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY ON (B)(6). THE SURGEON DETERMINED THAT THE ACETABULAR COMPONENT NEEDED TO BE RE-POSITIONED. IT WAS REMOVED AND REAMED AND A NEW COMPONENT WAS IMPLANTED. IT WAS STABLE. OPERATION WAS SUCCESSFULLY COMPLETED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6804060 ↗
• InjuryJun 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A TOTAL HIP REPLACEMENT (B)(6) 2016. HE CAME IN RECENTLY COMPLAINING OF GROIN PAIN. XRAY SHOWED A MEDIALIZED CUP. HE WAS SCHEDULED FOR A REVISION. HE WAS REVISED TO A NEW LARGER ACETABULAR CUP. THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury; Pain

  MAUDE report 6632674 ↗