MDM 626-00-38DRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540666000), received between Jan 11, 2017 and Sep 21, 2026 — classified as 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50845439 ↗
• InjurySep 2, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50572603 ↗
• InjuryJul 10, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF TOTAL FEMUR GMRS. CAUSE OF REVISION: DISLOCATION. 80MM EXTENSION PIECE AND ANTEVERTED PROXIMAL FEMUR EXPLANTED AND REVISED TO 60MM EXTENSION PIECE WITH A STANDARD PROXIMAL FEMORAL COMPONENT. UPDATE: ADM LINER DISLOCATED FROM THE MDM.

  Patient problems: Joint Dislocation

  MAUDE report 25777804 ↗
• InjuryJan 28, 2026Device Dislodged or Dislocated

  NO NEW INFORMATION

  Patient problems: Joint Dislocation

  MAUDE report 24203906 ↗
• InjuryFeb 28, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT WITH STRYKER COMPONENTS. IT IS FURTHER ALLEGED THAT THREE MONTHS AFTER THE RIGHT HIP REPLACEMENT, THE PLAINTIFF BEGAN TO EXPERIENCE CLICKING OF THE JOINT, ALONG WITH PAIN IN HER HIP, GROIN AND BUTTOCK AREA. BLOOD TEST REVEALED ELEVATED CHROMIUM (1.0) AND COBALT (7.3) LEVELS AS WELL AS ELEVATED ESR (9) AND CRP (2.8) LEVELS. ALLEGEDLY THE PATIENT WAS REVISED ON AN UNKNOWN DATE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 16452310 ↗
• InjuryOct 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT PRESENTED WITH THIGH PAIN. THERE WAS SUSPICION THAT THE STEM WAS LOOSE. LABS WERE ALSO DRAWN AND ELEVATED COBALT LEVEL WAS PRESENT. IN SURGERY IT WAS DETERMINED THAT THERE WERE NO LOOSE IMPLANTS. THE MDM WAS EXCHANGED FOR CERAMIC ON POLY TO ADDRESS THE ELEVATED COBALT LEVEL. NO OTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL."

  Patient problems: Pain

  MAUDE report 15672253 ↗
• MalfunctionJun 8, 2022Malposition of Device; Detachment of Device or Device Component; Malposition of Device; Detachment of Device or Device Component

  THE MDM METAL LINER WAS FOUND TO BE LOCKED SLANTWISE POSTOPERATIVE X-RAY. THE DOCTOR SAID THAT HE HAD CHECKED DURING THE SURGERY TO MAKE SURE THAT IT WAS NOT SLANTED. THE ROOT CAUSE IS UNKNOWN, BUT SINCE THERE IS NO COMPLICATIONS ON THE PATIENT AT THE MOMENT, HE WILL WAIT AND SEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634342 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REVISION TODAY ON A [LEFT] TOTAL HIP. REVISION WAS DUE TO FREQUENT DISLOCATIONS. THE STRYKER CUP WAS REMOVED AND A COMPETITOR CUP WAS IMPLANTED WITH A NEW STRYKER HEAD." SPOKE TO REP. THE ADM/ MDM POLY INSERT WAS SEPARATING FROM THE MDM METAL LINER. REP PROVIDED USAGE SHEETS FOR CURRENT AND PRIOR REVISIONS, AND CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 13857025 ↗
• InjuryOct 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. NOTED ON THE SHEET: "REASON: DISLOCATION." SPOKE TO REP. PATIENT PRESENTED WITH A DISLOCATION. SURGEON ATTEMPTED CLOSED REDUCTION, WHICH FAILED, AND DECIDED TO REVISE. INTRA-OPERATIVELY, THE METAL LINER WAS WELL-FIXED TO THE SHELL, THE POLY INSERT WAS OUT OF THE METAL LINER, AND THE FEMORAL HEAD WAS IN THE POLY INSERT. PATIENT WAS REVISED TO AN LFIT V40 HEAD AND CONSTRAINED LINER. BRANCH PROVIDED THE PRIMARY IMPLANT SHEET. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 10619038 ↗
• InjuryAug 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. REVISED AN MDM LINER AND INSERT AND 22 LFIT HEAD DUE TO CHRONIC DISLOCATION. HE REVISED TO A CONSTRAINED. ORIGINALLY DONE (B)(6) 2019 IN (B)(6).

  Patient problems: Injury

  MAUDE report 10450097 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN COVERING A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2020, THE REP WAS TOLD THE PATIENT HAD A PREVIOUS REVISION 'ABOUT A YEAR AGO' DUE TO DISLOCATION. SURGEON REPORTED PATIENT FACTOR OF "BAD SPINE". IT IS UNKNOWN WHICH DEVICE(S) MAY HAVE DISLOCATED OR DISASSOCIATED, BUT THE SURGEON DID REPORT THAT HE REVISED A 50MM SHELL TO A 52MM SOLID-BACK SHELL. REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9822947 ↗
• MalfunctionFeb 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MDM LINER DOESN'T SEEM TO LOCK UP ENOUGH IN POST-OPERATIVE X-RAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671073 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED INFECTION (IT WAS NOT REPORTED TO THE REP IF INFECTION WAS CLINICALLY CONFIRMED). THE PATIENT'S ENTIRE HIP CONSTRUCT (STEM, HEAD, ADM/ MDM LINER CONSTRUCT, SHELL SCREW) WAS REVISED TO A NEW SHELL, SCREW, POLY LINER, STEM, AND HEAD. SURGEON REPORTED THERE ARE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS AND CITED A PATIENT FACTOR OF DESTRUCTIVE IV DRUG USE. REP PROVIDED THE PRIMARY AND REVISION IMPLANT REPORTS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9495516 ↗
• InjuryAug 13, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH A TRITANIUM ACETABULAR CUP IN HER RIGHT HIP ON (B)(6) 2016 AND BEGAN EXPERIENCING PAIN AND DISCOMFORT. IT IS FURTHER ALLEGED DIAGNOSTIC WORKUP REVEALED DEVICE LOOSENING AND IN LIGHT OF WORSENING SYMPTOMS SHE WAS TAKEN BACK FOR REVISION SURGERY TO HER RIGHT HIP ON (B)(6) 2019. ALLEGEDLY "DURING SURGERY, MICROMOTION OF THE CUP WAS OBSERVED. THE REVISION SURGEON NOTED BLACKISH DISCOLORATION AT THE INTERFACE BETWEEN ACETABULAR CUP AND LINER. THE ACETABULAR CUP WAS NOTED TO HAVE BEEN PRIMARILY ADHERED BY FIBROUS TISSUE".

  Patient problems: Discomfort; Inadequate Osseointegration; Injury; Pain

  MAUDE report 8887648 ↗
• InjuryJun 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. CONTACTED US FOR A MDM LUXATED BY A PATIENT WITH A THA. THE PRIMARY SURGERY TOOK PLACE IN 2014 (EXETER STEM AND TRITANIUM SOLID CUP). THERE WAS AN ACETABULAR REVISION IN 2017. AN MDM LINER WAS PLACED. THIS WAS LUXATED. THE MDM LINER WAS REMOVED AND A CONSTRAINED LINER WAS PLACED. THE V40 22.2 / +3 HEAD WAS OUT OF DE X3 RESTORATION LINER (B)(6) 20019). ADDITIONAL PATIENT RECORDS/ X-RAYS AND OPERATION REPORTS ARE NOT AVAILABLE IN THIS CASE UPDATE BY OLIVE FLOOD (B)(6) 2019 BASED ON MEDICAL REVIEW. THIS PI RELATES TO THE SECOND REVISION SURGERY WHICH OCCURRED (B)(6) 2019 DUE TO DISLOCATION. AN X-RAY ON (B)(6) 2019, DOCUMENTED AN INTRAPROSTHETIC DISLOCATION OF THE MDM CONSTRUCT WITH MIGRATION OF THE STEM IN SUPERIOR DIRECTION. CUP SHELL AND STEM POSITION REMAIN UNCHANGED FROM PREVIOUS DESCRIPTIONS (SHELL MALPOSITION) BECAUSE RETAINED DURING REVISION SURGERY IN 2017 WITH ONLY CONVERSION OF THE BEARING IN THE TRIDENT SHELL FOR AN MDM CONSTRUCT WITH NEW V40 22-MM/+3 FEMORAL HEAD. A SECOND REVISION SURGERY WAS PERFORMED ON APRIL 23,2019 WITH EXCHANGE OF THE MDM BEARING FOR A CONSTRAINED CUP INSERT SYSTEM WITH NEW V40 22- MM/+0 FEMORAL HEAD. THE NEW ARTHROPLASTY CONDITION WAS DOCUMENTED

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8745423 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/ MDM INSERT FROM THE MDM METAL LINER. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR DISLOCATION WAS REPORTED TO THE REP. THE POLY INSERT, FEMORAL HEAD AND STEM WERE REVISED TO STRYKER DEVICES (THERE ARE NO ALLEGATIONS AGAINST THE HEAD, THE SURGEON WANTED TO IMPLANT A STEM WITH A GREATER OFFSET). REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8664399 ↗
• InjuryMay 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION OF MDM POLY INSERT FROM THE MDM METAL LINER CAUSED WHEN THE PATIENT GOT UP FROM A LOW, SOFT COUCH. THE LINER CONSTRUCT AND FEMORAL HEAD WERE REVISED TO A CONSTRAINED LINER AND A FEMORAL HEAD OF THE SAME CATALOG NUMBER (THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD). REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PRIOR SURGERIES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8654590 ↗
• InjuryMay 21, 2019Malposition of Device; Malposition of Device

  AS REPORTED: "CUP, HEAD, LINERS REMOVED DUE TO METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8627309 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ABOUT 5 YEARS BEFORE, MDM AND ACCOLADE2 WAS IMPLANTED. ALTHOUGH THE TIMING WAS UNDECIDED, WHEN A PATIENT VISITED THE HOSPITAL, THERE WAS INFLAMMATION SUSPECTED OF ARMD/ALVAL. CURRENTLY UNDER OBSERVATION.

  Patient problems: Inflammation; Reaction

  MAUDE report 8379192 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR PATIENT'S REVISION ON (B)(6) 2019. PATIENT HAD PRIMARY TOTAL RIGHT HIP ARTHROPLASTY (B)(6) 2016. DOCTOR PERFORMED HIP REVISION ON (B)(6) 2018 [(B)(4)] AND CONVERTED TO MDM CONSTRUCT. DOCTOR SAID PATIENT WAS BENDING DOWN TO FEED DOGS AND FELT POP IN HER HIP. X-RAY SHOWED PATIENT'S HIP DISLOCATED. CLOSED REDUCTION PERFORMED. DOCTOR DECIDED TO PERFORM SECOND REVISION AND UPON EXPOSURE FOUND STEM WELL FIXED AND ALIGNED, THE 22.2MM HEAD WELL FIXED TO THE STEM BUT DISASSOCIATED FROM THE ADM X3 POLY, AND THE POLY LOOSE FROM THE MDM LINER. THE LINER WAS WELL FIXED TO THE CUP AND THE CUP WAS WELL FIXED AND WELL ALIGNED. DOCTOR STATED THAT THE DISASSOCIATION COULD HAVE HAPPENED EITHER PRIOR TO THE CLOSED REDUCTION OR DURING THE CLOSED REDUCTION. HE THEN PROCEEDED TO REMOVE 22.2 FEMORAL HEAD WITH BONE TAMP AND MALLET AND MDM LINER FROM CUP USING A OSTEOTOME AND MALLET. DOCTOR IMPLANTED A TRIDENT 0° CONSTRAINED ACETABULAR INSERT SIZE D AND 22.2 X 0 V40 FEMORAL HEAD. PATIENT HAD A SPINAL FUSION PRIOR TO INITIAL SURGERY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8319137 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "ELEVATED COBALT METAL LEVELS". SPOKE TO REP. PATIENT WAS REVISED.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7861618 ↗
• MalfunctionFeb 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  JUST AFTER OPENING THE MDM COBALT CHROME LINER, THE SURGEON NOTICED THAT SOME PAPER (SIMILAR TO A STICKER OR LABEL) WAS ATTACHED TO THE INNER SIDE OF THE LINER ITSELF. HE WAS ABLE TO CLEAN THE LINER USING SOME ALCOHOL AND THEN IMPLANT IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302812 ↗
• MalfunctionMay 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MDM LINER WAS IMPACTED, LATER DURING THE CASE WAS FOUND TO BE DISLODGED. SURGEON WANTED A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6591787 ↗
• InjuryJan 11, 2017Device Dislodged or Dislocated; Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF LEFT HIP DUE TO CHRONIC DISLOCATION, CONVERTED TO A CONSTRAINED LINER.

  Patient problems: Injury; Joint Dislocation; No Information

  MAUDE report 6243797 ↗