MDMRecalls & reported problems across all models
Howmedica Osteonics Corp. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 181
- Deaths reported
- 0
- Injuries reported
- 171
- Recalls
- 0
We found 6 models of MDM by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2017 and Sep 21, 2026 — classified as 171 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (87 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MDM problems
Device problems
- Device Dislodged or Dislocated87
- Insufficient Device Problem Information31
- Adverse Event Without Identified Device or Use Problem17
- Degraded15
- Corroded10
- Unstable10
- Detachment of Device or Device Component9
- Malposition of Device8
Patient problems
- Injury74
- Joint Dislocation69
- Pain32
- Foreign Body Reaction17
- Metal Related Pathology17
- Ambulation or Postural Difficulties16
- Unspecified Infection13
- Inflammation12
MDM models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MDM 626-00-42EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented75 reports
- MDM 626-00-46FProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented62 reports
- MDM 626-00-38DProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24 reports
- MDM 626-00-48GProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate12 reports
- MDM 626-00-36CProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate5 reports
- MDM 626-00-52HProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
Recent MDM adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 27, 2026Malposition of Device
THE FOLLOWING INFORMATION WAS PROVIDED: POSTOPERATIVE PHOTOGRAPHS REVEALED THAT THE MDM LINER HAD NOT BEEN POSITIONED CORRECTLY, SO THE WOUND WAS REOPENED AND THE LINER REPOSITIONED.
Patient problems: Insufficient Information
MAUDE report 25299616 ↗InjuryJan 28, 2026Device Dislodged or Dislocated
InjuryDec 17, 2025Degraded; Degraded
ADDITIONAL INFORMATION RECEIVED 25-MAR-26, "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION HIP SURGERY "[ON (b)(6) 2026]" FROM A PRIMARY HIP TO AN FDA AND IRB APPROVED STRYKER COMPASSIONATE USE PSS DEVICE. THE PATIENT'S PELVIS WAS REPORTED AS FRACTURED, AND IT REQUIRED THIS DEVICE ALONG WITH MULTIPLE SCREWS AND A RESTORATION MODULAR FEMORAL HIP STEM TO RESTORE STABILITY TO THE JOINT."
Patient problems: Bone Fracture(s); Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Periprosthetic fracture
MAUDE report 23829951 ↗InjurySep 22, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem
NO NEW INFORMATION.
Patient problems: Loss of Range of Motion; Metal Related Pathology
MAUDE report 23106952 ↗InjuryJul 28, 2025Unstable; Unstable
AS REPORTED: "REVISION OF LEFT TOTAL HIP DONE TODAY. THIS PATIENT PRESENTED WITH A PERIPROSTHETIC FRACTURE OF HIS RIGHT HIP WHICH WAS COMPETITOR TOTAL HIP. ORIGINALLY THE LEFT HIP WAS NOT A PROBLEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2025 TO ADDRESS THE FRACTURE USING COMPETITOR PRODUCTS. AFTER THAT SURGERY IT WAS DISCOVERED THAT THE LEFT HIP HAD DISLOCATED. THE LEFT HIP WAS REDUCED AND TRANSFERRED FROM TRAUMA SERVICE TO JOINT REPLACEMENT SERVICE. IT WAS DISCOVERED THAT THE 28MM HEAD HAD DISASSOCIATED FROM THE MDM POLY LINER. IT IS THOUGHT THAT THIS DISASSOCIATION OCCURS WHEN THE HIP WAS REDUCED. THE REVISION TODAY WAS TO ADDRESS THE INSTABILITY OF THE LEFT HIP. MDM IMPLANTS WERE REMOVED AND A CONSTRAINED LINER WAS PLACED. IT WAS ALSO DECIDED TO GO FROM A +4 NECK LENGTH TO A +8 TO ADDRESS LIMB LENGTH DISCREPANCY. NO FURTHER INFORMATION AVAILABLE FROM SURGEON OR HOSPITAL." REP CONFIRMED THAT INTRA-OPERATIVELY, THE POLY WAS FOUND FLOATING IN THE JOINT.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 22638120 ↗InjuryJun 25, 2025Corroded; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Corroded; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. THE FOLLOWING WERE OBSERVED OR REPORTED BY THE SURGEON INTRA-OP: BLACK TISSUE IN THE PATIENT. BLACK MATERIAL ON THE MDM METAL LINER ON THE SIDE THAT FACES THE SHELL. THE MDM LINER WAS LOOSE INSIDE THE SHELL. ONE OF THE THREE SCREWS IN THE SHELL WAS SITTING PROUD, SURGEON REPORTED THIS WAS THE LIKELY CAUSE OF THE LINER BEING LOOSE. THE SCREW DID NOT APPEAR TO BE CROSS-THREADED OR WORN. THE BONE GRAFT BEHIND THE SHELL HAD NOT FULLY INCORPORATED INTO THE ACETABULUM, CAUSE THE SHELL TO NOT BE OPTIMALLY SEATED. THE SHELL, SCREWS, MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WERE REVISED TO A MULTIHOLE SHELL WITH AUGMENTS AND SCREWS, A POLY LINER, AND A 40MM FEMORAL HEAD.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 22325995 ↗InjuryMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAD A PRIMARY HIP REPLACEMENT WHERE AN MDM LINER, POLY INSERT, AND 28 CERAMIC HEAD WAS IMPLANTED. UPON FOLLOW UP THE LINER WAS STILL ATTACHED TO THE CUP AND THE HEAD WAS STILL ATTACHED TO THE STEM, BUT THE POLY INSERT HAD DETACHED FROM THE LINER AND HEAD AND WAS DISLODGED IN PATIENT. THE SURGEON PERFORMED A REVISION SURGERY AND REMOVED THE HEAD, LINER AND INSERT. HE REPLACED IT WITH A CONSTRAINED LINER.
Patient problems: Joint Dislocation
MAUDE report 22097127 ↗InjuryApr 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAD A REVISION DUE TO DISLOCATION AND SUSPECTED HEAD DISSOCIATION.
Patient problems: Joint Dislocation
MAUDE report 21738767 ↗InjuryMar 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PT DISLOCATED THR WITH MDM WHICH ALSO DISSOCIATED. STEM ALSO REMOVED AND ANTEVERTED 10° AND REINSERTED. THE ADM POLY INSERT SEPARATED FROM THE MDM METAL LINER AND THE FEMORAL HEAD SEPARATED FROM THE ADM POLY INSERT. THE METAL LINER WAS NOT REVISED. THE STEM WAS REVISED AS THE VERSION NEEDED ANTEVERTING BY 10 DEGREES TO PREVENT FURTHER DISLOCATIONS. A NEW EXETER STEM WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 21593125 ↗InjuryMar 3, 2025Degraded; Patient-Device Incompatibility; Degraded; Patient-Device Incompatibility
THE FOLLOWING WAS REPORTED: AROUND AUTUMN 2024, THE PATIENT WAS FOUND TO HAVE A METAL (COBALT CHROME) ALLERGY, AND THERE WAS A POSSIBILITY THAT THE REVISION WOULD BE PERFORMED AGAIN. AFTER THAT, THE PATIENT REQUESTED THAT THE SURGERY BE PERFORMED. REVISION THA WAS PERFORMED ON THE PATIENT. ALTHOUGH THERE WAS NO LOOSENING OR MALPOSITIONING OF THE IMPLANTS OR ANY NOTICEABLE DAMAGE, DAMAGE TO THE SOFT TISSUE (PARTICULARLY THE GLUTEUS MEDIUS MUSCLE) WAS OBSERVED. WHEN THE IMPLANTS WERE REMOVED, WHITE TISSUE WAS FOUND TO BE STUCK TO THE INNER SURFACE OF THE CUP (BETWEEN THE TRIDENT II-MDM LINER). REQUEST FROM THE DOCTOR: ALTHOUGH IT IS THOUGHT THAT THIS PHENOMENON MAY BE DUE TO AN ALLERGIC REACTION OF THE PATIENT TO THE CO-CR ALLOY IMPLANT, THE DOCTOR BELIEVES THAT THERE MAY BE OTHER FACTORS INVOLVED, AS THE SOFT TISSUE DAMAGE WAS SEVERE AND THERE WAS A LOT OF TISSUE ADHESION BETWEEN THE CUP AND LINER. THE DOCTOR HAS REQUESTED THAT STRYKER INVESTIGATE THE EXTENT AND CAUSE OF DAMAGE AND WEAR OF THE DEVICES THAT WAS REMOVED ON (B)(6).
Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology
MAUDE report 21511250 ↗InjuryFeb 26, 2025Detachment 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 LEFT HIP WAS REVISED AFTER THE FOLLOWING SERIES OF EVENTS: PATIENT FELL 4 DAYS POST-OP AND DISLOCATED. A CLOSED REDUCTION WAS PERFORMED. AN X-RAY TAKEN AFTER THE CLOSED REDUCTION DIDN'T 'LOOK RIGHT,' AND AN OPEN REDUCTION WAS PERFORMED. IT WAS OBSERVED THAT THE POLY INSERT WAS FLOATING IN THE JOINT - IT WAS OFF OF THE FEMORAL HEAD AND OUT OF THE METAL LINER (IT IS NOT KNOWN WHICH SEPARATION OCCURRED FIRST). A NEW FEMORAL HEAD AND ADM/ MDM POLY INSERT WERE IMPLANTED. THE ORIGINAL POLY AND FEMORAL HEAD WERE RE-ASSEMBLED AT THE BACK TABLE TO DEMONSTRATE TO THE SURGEON THE FORCE NEEDED TO ASSEMBLE THE IMPLANTS. THE REP PROVIDED PICTURES SHOWING THE POLY INSERT BEING DISLOCATED AND DISSOCIATED. THE SURGEON WOULD LIKE THIS EVENT AND DEVICES INVESTIGATED, AND WOULD LIKE THE INVESTIGATION RESULTS. THE DEVICES ARE AVAILABLE FOR RETURN, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 21467586 ↗InjuryFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REVISED A RIGHT HIP LINER AND HEAD DUE TO THE MDM METAL LINER DISENGAGING FROM THE SHELL AND OVERALL INSTABILITY. HE TIGHTENED ONE OF THE ACETABULAR SCREWS A COUPLE OF TURNS AND RE-IMPLANTED A NEW MDM LINER AND WENT FROM A -4MM HEAD TO A +12MM HEAD.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 21464835 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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