NA 1365-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 412 adverse event reports that list this exact device (DI 10603295033899), received between Feb 21, 2013 and Sep 11, 2026 — classified as 403 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (90 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. 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 412 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell and broke lateral side of the bone. Surgeon removed the Summit stem and implanted a revision stem. Surgeon swapped out the liner and head also.DOI: (b)(6) 2013.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 50734091 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2009, patient had a surgery of total hip arthroplasty indicated for osteoarthritis of the right hip. On (b)(6) 2026, patient was revised due to elevated metal ions. There was some synovitis and metallosis present. A thorough synovectomy was performed. DOI: (b)(6) 2009. DOR: (b)(6) 2026. Affected part: Right hip. (b)(4) is linked to (b)(4).

  Patient problems: Arthritis; Foreign Body Reaction; Synovitis

  MAUDE report 50695089 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6)2009, patient had a surgery of total hip arthroplasty indicated for osteoarthritis of the left hip. (b)(6)2024: Patient is experiencing left knee pain for 3 weeks. Pain is expected to be secondary to left knee osteoarthritis with exacerbation. No implants are currently present in the knee. Patient underwent a left knee injection and arthrocentesis.On (b)(6)2025, patient was revised due to developing pain in the left hip. Patient has a history of metal-on-metal prosthesis on both sides. Patient had metal ions assessed which unfortunately were significantly elevated. Through the operation, it was identified there was some mildly hemorrhagic bursitis which was carefully debrided. There were some inflamed synovial fronds both anteriorly and posteriorly and these were debrided. There was significant bony overgrowth anteriorly and this was debridedPatient reports experiencing a sensation of grinding in her hip when bending over to tie her shoe but does not experience any associated pain. Patient recalls an isolated incident of pain on the contralateral side but has not experienced any subsequent discomfort. Patient reports satisfactory progress with her left hip,

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Metal Related Pathology; Pain; Synovitis

  MAUDE report 50691091 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50453565 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SEPTIC WASHOUT. EXCHANGED HEAD AND LINER.

  Patient problems: Sepsis

  MAUDE report 25049189 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY AND FRACTURE. NO ADDITIONAL INFO. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24266678 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: (B)(6) 2020. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23468347 ↗
• InjuryNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HIP HAD DISLOCATED A FEW TIMES ACCORDING TO THE SURGEON. THEY DECIDED TO REPLACE THE NEUTRAL LINER WITH A LIPPED LINER AND THE APPROPRIATE SIZE HEAD. THEY SAID THAT ALL THE COMPONENTS LOOKED LIKE THEY WERE IN THE CORRECT ORIENTATION AND THAT PATIENT MAY JUST BE NON-COMPLIANT. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23455533 ↗
• InjuryNov 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION HIP SURGERY BECAUSE THE PINNACLE MARATHON LINER SEEMED TO HAVE BROKEN WHICH LEAD TO THE METAL FEMORAL HEAD RUBBING AGAINST THE METAL CUP. THE CUP, LINER AND HEAD WERE ALL CHANGED AND THE STEM WAS RETAINED WITH NO DAMAGE TO IT.

  Patient problems: Insufficient Information

  MAUDE report 23453078 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REPLACED METAL LINER IN ACETABULAR CUP WITH POLY LINER AND TS CERAMIC HEAD DUE TO INCREASE OF METAL IONS. NO OTHER COMPONENTS WERE REPLACED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 23356524 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED FOR A TOTAL HIP REPLACEMENT DUE CHRONIC INFECTION. ORIGINAL OPERATION FOR THE THR WAS ON AN UNKNOWN DATE IN 2018. ALL IMPLANTS WERE REMOVED AND STRYKER CEMENTED IMPLANTS IMPLANTED DUE TO INFECTION. ALL IMPLANTS WERE WELL FIXED WITH SIGNS ON BONE INTEGRATION AND ON GROWTH. NO FURTHER PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 22833170 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN I+D SURGERY DUE TO INFECTION. SURGEON REMOVED THE ACETABULAR DUAL MOBILITY LINER AND FEMORAL HEAD AND WASHOUT THE JOINT AND THEN REPLACED THE LINER AND HEAD WITH NEW IMPLANTS OF THE SAME SIZE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22557249 ↗
• InjuryJul 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATION AFTER NEAR ALMOST 5 YEARS. A NEW POLY AND A LONGER HEAD WAS IMPLANTED AND IS STABLE THROUGH A FULL RANGE OF MOTION. NO COMPLICATIONS. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22470943 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR INFECTED LEFT HIP. THE WOUND WAS DEBRIDED AND THE HEAD AND LINER WERE REMOVED. FOLLOWING THE WASHOUT, TEMPORARY OFF THE SHELF IMPLANTS WERE TEMPORARILY IMPLANTED TO ALLOW FOR A TEMPORARY WOUND CLOSURE WHILE THE ENTIRE SURGICAL FIELD WAS TORN DOWN AND REPLACED WITH AN ALL NEW STERILE SET-UP. A 36 HEAD AND LINER WERE PLACED. THERE ARE NO PRODUCT FAILURE OR PATIENT HARM ALLEGATIONS ATTRIBUTED TO THESE PRODUCTS--THEY WERE PLACED MERELY AS A CONSERVATIVE JOINT SPACER WHILE THE SURGICAL PROCEDURE 2ND STAGE WAS PREPARED. AFTER RE-OPENING THE SURGICAL WOUND, THE TEMPORARY 36 HEAD AND LINER WERE REMOVED AND DEFINITIVE PERMANENT IMPLANTS, A 40 HEAD AND LINER, WERE IMPLANTED AND PATIENT SUCCESSFULLY CLOSED. THERE WERE NO COMPLICATIONS. THERE WERE NO DELAYS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22327052 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURN TO SURGERY DUE TO AN INFECTED TOTAL HIP. HIS LINER AND HEAD WERE REMOVED AND THE JOINT WAS DEBRIDED. A NEW 36 LINER WAS PLACED WITH A METAL HEAD AS A TEMPORARY REPLACEMENT WHILE THE WOUND WAS CLOSED. THE PATIENT WAS REPREPPED AND DRAPED. THE LINER AND HEAD WAS REMOVED AGAIN. A NEW 40 LINER AND HEAD WERE PLACED. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22308758 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. PLAINTIFF UNDERWENT A RIGHT HIP REVISION DUE TO LOOSE FEMORAL COMPONENTS, BLOOD HEAVY AND METAL-ON-METAL OSTEOLYSIS. OPERATIVE NOTES INDICATED GREEN CLOUDY FLUID WAS ENCOUNTERED CONSISTENT WITH METALLOSIS. DOI: (B)(6) 2007 (LINER), DOI: (B)(6) 2011(HEAD), DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 22308433 ↗
• InjuryApr 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD DISLOCATED SEVERAL TIMES OVER THE PAST YEAR. SURGEON REMOVED THE HEAD AND LINER - REPLACED THEM WITH A CONSTRAINED LINER AN ANOTHER HEAD. NO LOSS OF TIME. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21763964 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION OF HEAD AND LINER.AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21756162 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. DOI: (B)(6) 2023 DOR: UNKNOWN AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 21754253 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD AND POLY WERE EXCHANGED AFTER DISLOCATION. POLY DEFORMATION WAS NOTED BY DOCTOR PRIOR TO EXTRACTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21723969 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21651810 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21610425 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. INFECTED SINGLE STAGE REVISION OF RIGHT HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21074065 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PAINFUL RIGHT THA. SURGEON REVISED HEAD AND LINER AND REMOVED SCREWS.

  Patient problems: Pain

  MAUDE report 20423749 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT HIP REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO INFECTION. AREA WAS WASHED OUT. ORIGINAL DATE OF SURGERY WAS (B)(6) 2024. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20351519 ↗