NA 1365-33-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10603295033509), received between Jul 7, 2017 and Apr 24, 2026 — classified as 108 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (26 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 112 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATED S-ROM HIP. CHANGES THE VERSION ON STEM AND CHANGED HEAD FROM 36+6 TO 36+9. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24980429 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD METAL ON METAL CONSTRUCT. PATIENT WAS REVISED DUE TO METALOSIS. RECORDS INDICATE 52X36 PINNACLE METAL LINER AND 36 +6 SROM METAL HEAD. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 24809271 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22358159 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A METAL-ON-METAL COMPONENT. PATIENT SHOWED OSTEOLYTIC LESION ON THE GREATER TROCH AND INCREASING PAIN. HEAD & LINER EXCHANGE WAS PERFORMED WITH BONE GRAFT PLACEMENT IN THE LESION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Pain

  MAUDE report 22140241 ↗
• InjuryOct 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF AN ULTAMET METAL ON METAL LINER 36X60MM AND S-ROM METAL HEAD ON THE LEFT SIDE. REASON FOR REVISION IS DUE TO METAL IONS IN THE BLOOD DUE TO METAL ON METAL DEBRIS. THESE COMPONENTS WERE IMPLANTED ON (B)(6) 2004. THE OTHER SIDE WAS REVISED PREVIOUSLY FOR THE SAME ISSUE. EXACT DATE WAS UNKNOWN FOR THE REVISION. THEY IMPLANTED A NEW POLY LINER AT THAT TIME. THOSE IMPLANTS REVISED WERE METAL LINER AND S-ROM METAL HEAD ON THE RIGHT SIDE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20577047 ↗
• MalfunctionJun 12, 2024Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE REACTION TO METAL DEBRIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF EVENT: 04 APR 2024. (RIGHT HIP). TREATMENT: NONE . ADDITIONAL EVENT INFORMATION: REVISION DUE TO METAL WEAR.

  Patient problems: Foreign Body Reaction

  MAUDE report 19518556 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED HIP. THE SURGEON REMOVED THE LINER AND HEAD AND ALL OF THE INFECTED AREA AND REPLACED IT WITH A NEW LINER AND HEAD. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19350662 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO METALLOSIS AND THE ULTAMET METAL ON METAL INSERT AND SROM METAL ON METAL FEMORAL HEAD WERE EXPLANTED. THESE COMPONENTS WERE REPLACED WITH AN ALTRX POLYETHYLENE LINER AND M-SPEC METAL FEMORAL HEAD. THE COMPONENTS ARE NOT AVAILABLE FOR RETURN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 18433984 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2008, PATIENT RECEIVED AN UNCEMENTED LEFT METAL-ON-METAL TOTAL HIP REPLACEMENT WITH S-ROM FEMUR AND PINNACLE CUP MOM TO ADDRESS OSTEOARTHRITIS. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2022, PATIENT HAD BOTH THE RIGHT AND THE LEFT TOTAL HIPS REVISED TO ADDRESS HEMATOGENOUS SEPSIS, FLUID COLLECTIONS IN BOTH HIPS, ACUTE PAIN AND SYNOVITIS OF THE LEFT HIP, AND CHRONIC ADVERSE REACTION TO METAL DEBRIS OF THE RIGHT HIP. THE LEFT HIP ALSO PRESENTED WITH GROSS PUS, BUT IN THIS CASE THE ROTATORS AND CAPSULE WERE STILL INTACT, THERE WAS NO EVIDENCE IN THE LEFT HIP OF CHRONIC ADVERSE REACTION TO METAL DEBRIS. CUP AND STEM WERE WELL-FIXED, WITH GOOD POSITIONS IN BOTH CASES, SO ONLY THE HEAD AND METAL LINER WERE EXCHANGED FOR POLYETHYLENE LINER AND METAL HEAD. HIP WAS WELL IRRIGATED AND DEBRIDED FOR TREATMENT OF THE INFECTION.

  Patient problems: Cyst(s); Low Blood Pressure/ Hypotension; Pain; Sepsis; Synovitis; Unspecified Infection

  MAUDE report 16223697 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL TOTAL SROM HIPS. SHE WAS REVISED DUE TO INFECTION IN BOTH HIPS. LOT NUMBER ON THE CUP WAS DAMAGED DURING EXPLANT AND UNRETRIEVABLE. THE LEFT SIDE WAS REVISED WITH HEAD AND LINER EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16101815 ↗
• InjuryOct 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2003; DATE OF EVENT: (B)(6) 2022; (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 15697619 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A MOM RTH PUT IN AROUND 2004. HE CAME IN WITH PAIN IN HIS HIP AND SWELLING. SURGEON DECIDED IT BEST TO REMOVE THE METAL LINER AND REPLACE IT WITH A POLY LINER. HE ALSO SWAPPED THE HEAD OUT DURING THIS TIME. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15191798 ↗
• InjuryJun 24, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING AROUND THE HIP, METALLOSIS, AND ADVERSE REACTION TO METAL DEBRIS WITH FLUID COLLECTION EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2022. (RIGHT SIDE). TREATMENT: REVISION OF THE LINER.

  Patient problems: Foreign Body Reaction; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 14801233 ↗
• InjuryJun 6, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD LEFT HIP REPLACED IN 2002. THERE WAS NO OP OR POST-OP REPORT OF THIS CASE AVAILABLE. SURGEON FOLLOWED UP ON THE PATIENT'S HIP REPLACEMENT BECAUSE OF A SMALL MASS THAT WAS EVIDENT DURING AN ULTRASOUND ADJACENT TO THE MEDIAL WALL OF THE ACETABULUM. IT WAS DECEIVED THAT THE ULTAMET METAL LINER AND METAL HEAD ARTICULATION COULD BE GENERATING METAL DEBRIS THAT COULD BE CAUSING LYSIS AROUND THE ACETABULAR CUP. THE METAL LINER, THE FEMORAL HIP BALL WAS EXPLANTED AND REPLACED WITH A POLYETHYLENE LINER AND A NEW HIP BALL. THE SROM FEMORAL STEM, SROM SLEEVE, AND PINNACLE ACETABULAR CUP WERE LEFT IN SITU. THE LOT AND CATALOGUE NUMBERS FOR THE IMPLANTS LEFT IN SITU AND EXPLANTED DID NOT HAVE LEGIBLE NUMBERS TO RECORD. THERE WAS NO SURGICAL DELAY. DOI: 2002. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Osteolysis

  MAUDE report 14602591 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14295026 ↗
• InjuryApr 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DATE OF IMPLANT: (B)(6) 2022, DATE OF REVISION: (B)(6) 2022, (RIGHT HIP). HEAD AND LINER REVISED. THIS COMPLAINT IS LINKED TO (B)(4) TO CAPTURE THE REOPERATION FOR HEMATOMA.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 14205377 ↗
• InjuryMar 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: CLOSED REDUCTION / MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 13824892 ↗
• InjuryMar 15, 2022Degraded; Degraded

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP, MOM REACTION. REVISION NOTES STATED THAT THERE WAS OBVIOUS DISTENTION OF POSTERIOR ROTATORS OR CAPSULE THAT WAS ASPIRATED AND FOUND TO BE MILKY COLORED. THERE WAS OBVIOUS METAL STAINING OF THE SYNOVIUM. THERE WAS CORROSION ON THE TAPER. MEDICAL RECORDS INDICATE THAT THE CORROSION ON THE TRUNNION OF THE FEMORAL STEM WAS CLEANED OFF. THE STEM AND SLEEVE WERE WELL-FIXED AND THEREFORE RETAINED. DOI: (B)(6) 2007, DOR: (B)(6) 2012, (LEFT HIP).

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 13770513 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HIP PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12827939 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS METAL ON METAL. METALOSIS PRESENTED. REVISION NECESSARY. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 12647297 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS BEING REVISED DUE TO PAIN/DISCOMFORT. DR. STATED SHE HAD MULTIPLE SURGERIES PRIOR. DOI: (B)(6) 2013, DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Discomfort; Pain

  MAUDE report 12344921 ↗
• InjuryJun 11, 2021Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS ADVERSE LOCAL TISSUE REACTION (ALTR) DATE OF IMPLANTATION:(B)(6) 2006. DATE OF REVISION: (B)(6) 2021. (RIGHT HIP) THE MEDICAL RECORDS HAVE BEEN REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT FAILURES. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT HIP REVISION TO ADDRESS DISLOCATION, SYNOVITIS, PAIN, METALLOSIS, OSTEOLYSIS, PSEUDOTUMOR, AND CORROSION OF THE STEM TRUNNION. THE SURGEON INDICATED AFTER REMOVAL OF THE HEAD FROM THE STEM THERE WAS CORROSION COMPATIBLE WITH METALLOSIS, THE CORROSION WAS CLEANED OFF THE TRUNNION. THERE WAS EXTENSIVE SUPERIOR ILIAC BONE LOSS. THE CENTRAL DOME SCREW WAS REMOVED FROM THE WELL-FIXED CUP. THERE IS NO INDICATION THE SCREW WAS REPLACED. REMOVAL OF THE METAL LINER DEMONSTRATED EXTREME BACKSIDE COBALT CHROME METALLOSIS. PSEUDOTUMOR INVADED THE ABDUCTOR MUSCULATURE AND THE SHORT EXTERNAL ROTATORS OF THE FEMUR, AND EXTENSIVE OSTEOLSYSIS OF THE MEDIAL ANTERIOR AND POSTERIOR PROXIMAL POROUS SLEEVE OF THE S-ROM COMPONENT. HOWEVER, THERE WAS RIGID FIXATION DISTALLY AND LATERALLY AND THE STEM WAS SOLID IN THE FEMUR. THE FEMORAL HEAD AND ACETABULAR LINER WERE REVISED. THE CENTRAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; Osteolysis; Pain; Synovitis

  MAUDE report 11984409 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP DONE IN 2005, ORIGINAL OPERATING SURGEON UNKNOWN. PATIENT WAS IMPLANTED WITH PINNACLE METAL LINER AND METAL HEAD. PATIENT WAS SUFFERING FROM METALLOSIS. THE SURGEON FELT PATIENT WOULD BENEFIT FROM A HEAD AND LINER EXCHANGE. METAL LINER REMOVED AND 52 ALTRX +4 10 LINER IMPLANTED. HEAD WAS A METAL 36+6, A TRIAL REDUCTION WITH A SIMILAR HEAD WAS DONE, AND WAS FOUND TO BE STABLE. REAL HEAD WAS OPENED AND IMPLANTED. DOI: (B)(6) 2005. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 11891596 ↗
• InjuryMay 12, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION REPORTED THAT THE PLAINTIFFS REVISION INVOLVED, IN PART, A FINDING OF AN ADVERSE TISSUE REACTION RELATED TO THE METAL-ON-METAL ARTICULATION, RELEASE OF A LARGE AMOUNT OF BROWNISH FLUID, AND DEBRIDEMENT AND REMOVAL OF BROWNISH FRIABLE TISSUE THROUGHOUT THE ENTIRE HIP JOINT, ALL DUE TO TOXIC HEAVY METAL/METAL ION COBALT AND CHROMIUM POISONING.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Arrhythmia; Depression; Discomfort; Distress; Dyspnea; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Numbness; Pain; Paresthesia; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11814340 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS PINNACLE METAL ON METAL LINER REVISED TO NEW POLY LINER. DOI: (B)(6) 2001. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 11813244 ↗