NA 1365-51-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 753 adverse event reports that list this exact device (DI 10603295033912), received between Jan 7, 2013 and Sep 22, 2026 — classified as 744 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (172 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 753 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Pain

  MAUDE report 50855210 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50847490 ↗
• InjuryJun 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL WHICH CAUSED PERIPROSTHETIC FRACTURE. THIS LED TO A DISLOCATION. THE STEM ROTATED. IT WAS REMOVED AND A MONOBLOC RECLAIM WAS PLACED. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC STEM LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 25664324 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO THIGH PAIN LEFT HIP. THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25565247 ↗
• InjuryJun 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION THA. CHANGED DEPUY HEAD AND COMPETITOR LINER. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25392866 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS FOR MOVED FROM INFECTED HIP. PINNACLE CUP, METAL ON METAL LINER, 36 METAL HEAD, CORAIL COLLARLESS STEM. ALL IMPLANTS REMOVED FROM INFECTED HIP. IMPLANTS SENT TO LAB, IMPLANTED APPROPRIATELY 20 YEARS AGO. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25303475 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN. THE METAL LINER WAS REMOVED AND REPLACED WITH A POLYETHYLENE LINER. THERE WERE NO PATIENT COMPLICATIONS AND THERE WAS NO FURTHER INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25202723 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT METAL ON METAL BEARING EXCHANGE. DOI-UNKNOWN, DOR-(B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 25056613 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  UPDATED ED: PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS RIGHT HIP AND BUTTOCK PAIN, ELEVATED SERUM COBALT AND CHROMIUM ION LEVELS, ASEPTIC LYMPHOCYTE DOMINATE VASCULITIS ASSOCIATED LESION (ALVAL), PAINFUL RIGHT METAL-ON-METAL TOTAL HIP ARTHROPLASTY, AND DISPLACED RIGHT FEMUR GREATER TROCHANTER FRACTURE. TREATMENT CONSISTED OF REVISION RIGHT TOTAL HIP ARTHROPLASTY, WITH MODULAR HEAD AND IINER EXCHANGE ONLY, AND RIGHT HIP ABDUCTOR TENDON REPAIR. PSEUDOTUMOR WAS DEBRIDED. FEMORAL STEM AND ACETABULAR CUP WERE WELL-FIXED AND RETAINED. METAL FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED, AND REPLACED WITH A CERAMIC HEAD AND A POLYETHYLENE LINER. A SMALL AMOUNT OF BLACK TRUNNIONOSIS WAS REMOVED FROM THE BASE OF THE TRUNNION--THE TRUNNION WAS OTHERWISE INTACT. THE GREATER TROCHANTER BONE FRAGMENT WAS SIGNIFICANTLY DISPLACED AND NOT A CANDIDATE FOR OSTEOSYNTHESIS FIXATION, SO AN ABDUCTOR TENDON REPAIR WAS PERFORMED IN LIEU OF THE ORIF OF THE TROCHANTER. THE SURGERY WAS TOLERATED WELL, WITH NO COMPLICATIONS. PATIENT WAS SEEN PRESENTING WITH BILATERAL MOM HIPS AND FOUND SHE WAS HAVING BILATERAL HIP PAIN, RIGHT GREATER THAN LEFT. PATIENT REPORTED THAT PAIN WAS WORSE WHEN SITTING; THE RIGHT SID

  Patient problems: Fatigue; Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24838799 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. THEY EXCHANGE METAL LINER TO STANDARD POLY LINER WITH NEW CERAMIC TITANIUM SLEEVED HEAD. DOI: (B)(6) 2007. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 24775216 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER AND HEAD WAS EXPLANTED DUE TO METALOSIS. REPLACED WITH CERAMIC TS HEAD AND POLY LINER. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 24764489 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CUP WAS MALPOSITIONED, CREATING CHRONIC DISLOCATION. 54 CUP REMOVED, LINER REMOVED, HEAD REMOVED. CUP REVISION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 24458208 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PINNACLE METAL LINER AND METAL HEAD WERE REMOVED BECAUSE OF METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 24302187 ↗
• InjuryFeb 2, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24239957 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24221642 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24101598 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED FOR INSTABILITY. NO IMPLANT ISSUES. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24006208 ↗
• InjuryJan 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING DISLOCATION, SO THE SURGEON CONVERTED TO A CONSTRAINED LINER AND SWAPPED THE FEMORAL HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23995460 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HIP WAS DISLOCATED. UPON VIEW OF THE PATIENT X-RAY, IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS MALPOSITIONED. THE CUP WAS VERTICAL AND DR. WANTED TO REVISE THE ACETABULAR COMPONENT. WHEN ASKED IF HE HAD ANY INFORMATION ON THE PATIENTS INITIAL SURGERY, HE SAID HE DIDN¿T HAVE ANY OF THE INFORMATION. HE WAS UNSURE OF WHERE THE PATIENT HAD THEIR SURGERY, WHO DID IT, OR WHEN IT WAS DONE. THE CUP WAS REMOVED AND THE PATIENT WAS PREPARED AND IMPLANTED WITH A REVISION MULTIHOLE CUP. AN ELEVATED RIM LINER WAS IMPLANTED AND A TRIAL REDUCTION WAS PERFORMED. STABILITY WAS CONFIRMED, SO THE REAL TS CERAMIC HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23863623 ↗
• InjuryDec 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LEFT HIP WAS REPLACED 15 YRS AGO AT A DIFFERENT HOSPITAL; THE EXACT DATE IS NOT KNOWN. X-RAYS SHOW THE LEFT HIP PARTIALLY SUBLUXED SUPERIOR AND LATERALLY. IT WAS DISCOVERED AFTER DISLOCATION THAT THE POLY LINER HAD ROTATED IN THE CUP TO A POSITION THAT ALLOWED THE FEMORAL HEAD TO ARTICULATED AGAINST THE INSIDE SUPERIOR PORTION OF THE ACETABULAR CUP GENERATING A FAIR AMOUNT OF TITANIUM WEAR DEBRIS. THE DEBRIS WAS IRRIGATED FROM THE HIP AREA. FOUR OF THE SIX ARD'S ON THE POLY LINER HAD BEEN SHEARED OFF. THERE WAS LOOSENING OF ACETABULAR LINER AT BONE TO IMPLANT INTERFACE. THE CONDITION OF THE CUP WAS ASSESSED AND FOUND TO BE ADEQUATE FOR CONTINUED USE. AN ALTRX LINER, 36MM X 58MM +4 10° WAS IMPACTED IN THE CUP AND A NEW FEMORAL HEAD WAS IMPACTED ON THE AML TRUNION. NO OTHER IMPLANTS WERE REMOVED/REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23757491 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. REPLACED WITH CONSTRAINED LINER. DOI- (B)(6) 2020. DOR- (B)(6) 2025. AFFECTED SIDE-UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23547354 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT¿S HIP WAS IMPINGING ANTERIORLY. LINER AND HEAD WERE EXTRACTED. DUAL MOBILITY WAS IMPLANTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23439416 ↗
• InjuryOct 31, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF RIGHT TOTAL HIP. THE PATIENT WAS REVISED HIP FOR INCREASED COCR LEVELS DUE TO METAL-ON-METAL HIP BEARING. THE SURGEON REMOVED LINER AND HEAD AND REPLACED IT WITH CERAMIC AND POLYETHYLENE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 23436677 ↗
• InjuryOct 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEONS PUT A CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23381550 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A LEFT PRIMARY HIP WAS DONE ON (B)(6) 2025. THE PATIENT WAS TAKEN FOR RECOVERY. PATIENT MADE A JERKING MOTION AND HAD SOME DISCOMFORT. THE STAFF DETERMINED THAT PATIENT HAD DISLOCATED. THE SURGEON, TOOK THE PATIENT BACK TO THE OR AROUND 2PM ON (B)(6) 2025. THE CUP, LINER, & SCREWS WERE REMOVED. THE SURGEON REPOSITIONED A NEW CUP, ADDED 2 SCREWS, AND A +4/10* LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 23006683 ↗