NA 1365-11-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295033073), received between Jan 7, 2013 and Dec 6, 2023 — classified as 1 death, 46 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Degraded; Degraded

  IT WAS REPORTED THAT ON FEB 21, 2008, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE IMPLANTS MONM, G2 STEM AND PINNACLE CUP. THE DATE IS UNKNOWN, BUT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023, AFTER SUFFERING A FEMUR FRACTURE AND ASSOCIATED PAIN. THE METAL LINER, METAL HEAD, AND G2 STEM WERE REMOVED AND REPLACED. PINNACLE CUP WAS LEFT ON THE BODY. ARMD WAS SUSPECTED BECAUSE BLACK DEPOSITS WERE FOUND ON THE TRUNNION OF THE REMOVED STEM AND INSIDE THE HEAD. THERE WAS A REQUEST FOR VERIFICATION OF THE REMOVED PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18277573 ↗
• InjuryOct 31, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT PRIMARY SURGERY VIA THA FOR OA FOR THE HIP JOINT AT ANOTHER FACILITY. WHEN THE PATIENT VISITED THIS HOSPITAL IN (B)(6) 2023 (DATE UNKNOWN), IT WAS CONFIRMED THAT THE PATIENT HAD SUSPECTED ARMD. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IN THIS SURGERY, THE HEAD AND METAL LINER WERE REMOVED. AS A RESULT, NO METALLOSIS WAS OBSERVED, AND THE PATIENT WAS JUDGED TO HAVE MILD ARMD. ALTHOUGH THERE WAS SOME DAMAGE TO THE STEM AND TRUNNION, THERE WAS NO LOOSENESS IN THE OUTER CUP OR STEM, SO IT WAS DETERMINED THAT ONLY THE SLIDING SURFACE (LINER/HEAD) SHOULD BE REPLACED. THE LINER WAS REPLACED FROM METAL TO POLYETHYLENE, AND THE HEAD WAS REPLACED FROM METAL TO A REVISION CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2009. DOE: (B)(6) 2023.

  Patient problems: Foreign Body Reaction

  MAUDE report 18039218 ↗
• InjuryAug 31, 2023Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  MEDICAL RECORDS WERE RECEIVED: AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION METAL ON METAL BEARING, ELEVATED METAL IONS AND HIP PAIN. OPERATIVE NOTE REPORTED THERE WAS A DISHWATER TYPE FLUID FROM THE JOINT, SURGICAL DELAY DUE TO METAL LINER DIFFICULT TO DISENGAGE. ON (B)(6) 2023 MRI SPINE, MUSCLE SPASM AND LEFT LEG WEAKNESS. HOWEVER THERE WAS NO INVASIVE TREATMENT OR REVISION NOTED. DOI: (B)(6) 2008; DOR: (B)(6) 2015: LEFT HIP.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Fatigue; Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17661089 ↗
• InjuryMar 10, 2023Naturally Worn; Naturally Worn

  LITIGATION RECORD RECEIVED. LITIGATION RECORD STATED THAT ON (B)(6) 2006, PLAINTIFF HAD A METAL ON METAL PINNACLE SYSTEM IMPLANTED. ON (B)(6) 2022, PATIENT WAS FORCED TO GO SURGICAL REMOVAL OF THE DEFECTIVE PINNACLE SYSTEM OF PATIENT'S HIP AT THE HOUSTON METHODIST HOSPITAL IN HOUSTON. THE PLAINTIFF SUFFERED HEAVY METAL POISONING FROM TOXIC HEAVY METALS RESULTING INJURY AND REQUIRING SURGERY. AS A RESULT OF SURGICAL REMOVAL, PLAINTIFF SUFFERED INJURY TO HIS MUSCLE AND TISSUE AND SUFFERED ADDITIONAL SCAR TISSUE FORMATION AND EXPERIENCED SIGNIFICANT PAIN, INJURY BY METALLOSIS, METAL WEAR AND METAL POISONING. DOI: (B)(6) 2006; DOR: (B)(6) 2022; UNKNOWN AFFECTED SIDE.

  Patient problems: Adhesion(s); Foreign Body Reaction; Metal Related Pathology; Nerve Damage; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16522989 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO ESC CONSTRAINED LINER DISLOCATED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16379297 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16103468 ↗
• InjuryAug 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  70-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT HIP REVISION TO TREAT IMPINGEMENT SECONDARY TO DISLOCATION AND LINER DISASSOCIATION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED METALLOSIS CAUSED BY METAL DEBRIS. THE LINER WAS DISASSOCIATED DUE TO LOCKING MECHANISM FAILURE, CAUSING THE SUMMIT FEMORAL STEM TO IMPINGE ON THE FAILED LOCKING RING GENERATING WEAR ON THE TRUNNION AND METAL DEBRIS. THE CUP AND STEM WERE WELL-FIXED AND RETAINED. THE PATIENT A BIMENTUM DUAL MOBILITY ARTICULATING SURFACE TO REPLACE THE REVISED HEAD AND LINER. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. HEAD, LINER AND STEM WERE REVISED. DOI: (B)(6) 2008 (CUP, STEM); DOI: (B)(6) 2017 (HEAD, LINER). DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Unspecified Musculoskeletal problem

  MAUDE report 15232293 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO PATIENT SUFFERING A DISLOCATION. AFTER THE SURGEON OPENED HER UP, HE NOTICED THAT THE POLY LINER DISASSOCIATED FROM THE SHELL. THERE WAS LOOSENING OF THE POLY LINER. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14603445 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. OPERATIVE NOTE REPORTED PSEUDO CAPSULE, A SMALL AMOUNT OF SLIGHTLY CLOUDY SYNOVIAL FLUID. HOWEVER, THERE WERE NO DAMAGE IN THE HEAD, LINER AND ACETABULUM. DOI: (B)(6) 2008; DOR: (B)(6) 2013; LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Laxity; Swelling/ Edema

  MAUDE report 13769514 ↗
• InjuryJan 27, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POLY WEAR AND METAL WEAR WAS THE REASON FOR REVISION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11238288 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. EXTRACTED METAL INSERT LINER AND COCR HEAD. THE SECTOR CUP AND FEMORAL STEM WHERE STILL INTACTED, THEY WERE NOT EXTRACTED. IMPLANTED AN ALTRX +4 NEUTRAL LINER AND A TS BIOLOX DELTA CERAMIC 32 +1.5 HEAD. NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 11079371 ↗
• InjuryDec 17, 2020Noise, Audible; Noise, Audible

  VOLUNTARY REPORT RECEIVED UNDER MW5097266. IT WAS REPORTED THAT PATIENT SUFFERED A SUBCAPITAL FRACTURE OF HER RIGHT HIP. BIPOLAR HIP PLACED ON 2020. THE BIPOLAR HIP ASSEMBLY FAILED AND WAS REMOVED ON 2020. IT WAS REPLACED WITH ANOTHER DEVICE. THE SECOND DEVICE FAILED AND WAS REPLACED ON 2020. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11026998 ↗
• InjuryOct 23, 2020Noise, Audible; Noise, Audible

  IT WAS REPORTED THE PATIENT HAD TO BE REVISED AGAIN BECAUSE THE PLASTIC LINER DISASSOCIATED FROM THE BIPOLAR SHELL. PATIENT HAD COMPLAINED OF A CLICKING NOISE AND AN X-RAY SHOWED THE DISASSOCIATION. PATIENT WAS REVISED TO A UNIPOLAR CONSTRUCT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10726180 ↗
• InjuryJul 21, 2020Naturally Worn; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA THA AT HYOGO PREFECTURAL REHABILITATION CENTRAL HOSPITAL. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE HEAD AND THE LINER BECAUSE THE PATIENT HAD A PAIN WHICH WAS CAUSED BY PSEUDOTUMOR. THE REASON OF PSEUDOTUMOR WAS THOUGHT TO BE MOM. THE STEM WAS REMAINED. THE REVISION SURGERY WAS COMPLETED WITH 240 MINUTES DELAY. DURING THE SURGERY, AT THE TIME OF REMOVAL OF THE HEAD, THE SURGEON FOUND ADHERING SUBSTANCE WHICH WAS CONSIDERED TO BE METAL DEBRIS. THE SURGEON REQUESTED TO INVESTIGATE THE COMPONENT OF THE ADHERING SUBSTANCE. THE SURGEON COMMENTED THAT THE PSEUDOTUMOR THOUGHT TO BE CAUSED BY MOM. THE EXPLANTED HEAD, LINER AND REMAINED STEM WILL NOT BE RETURNED. THE ADHERING SUBSTANCE WHICH WAS FOUND BY THE SURGEON WILL BE SHIPPED TO YOUR SITE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 10303055 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR MECHANICAL FAILURE, METAL ON METAL, RIGHT THA. OPERATIVE NOTE REPORTED THAT THERE WAS BLACK STAINING OF THE SOFT TISSUE INSIDE THE PSEUDOCAPSULE. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 10216432 ↗
• InjuryJun 4, 2020Naturally Worn; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP (P/N: 121781048, (B)(6) PRODUCT), THE LINER (P/N: 121889148) AND THE HEAD (P/N: 136511500) DUE TO THE OSTEOLYSIS WHICH WAS SEEMED TO BE CAUSED BY METAL DEBRIS. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 10117386 ↗
• InjuryMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS LEFT HIP DISLOCATIONS- REMOVED NEW LINER AND IMPLANTED CONSTRAINED LINER WITH LOCKING RING. PATIENT HAD SOME SPINE ISSUES CAUSING NERVE AND MUSCLE WEAKNESS. DOI: (B)(6) 2010. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Weakness

  MAUDE report 9898271 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND PERIPROSTHETIC INFECTION. ASPIRATION WAS NEGATIVE FOR BACTERIA BUT ALSO HAD 111 WHITE BLOOD CELLS. INTRAOPERATIVELY, THERE WAS GROSS PUS, BONE LOSS, A DEFICIENCY OF THE POSTERIOR COLUMN RELATED TO THE INFECTION AND FRACTURE CRACKS IN THE PROXIMAL FEMUR. IMPLANTS WERE REMOVED AND A NON-ARTICULATING SPACER CONSTRUCT OF UNKNOWN MANUFACTURER WAS PLACED. REVISION NOTES ON THE SECOND REVISION FOR REMOVAL OF SAID SPACER ON (B)(6) 2018 INDICATE PRESENCE OF A DARK MURKY FLUID CONSISTENT WITH METALLOSIS AS WELL AS CHALKY, METALLOSIS TYPE DEBRIS. DOI: (B)(6) 2006; DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: Abscess; Foreign Body Reaction; Injury; No Code Available; Pain; Unspecified Infection

  MAUDE report 9852878 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: UNKNOWN. DOR: MARCH 2, 2020. AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 9845820 ↗
• InjuryNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION. DOI: (B)(6) 2019. DOR: UNKNOWN; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9353805 ↗
• InjuryOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION AND LOOSENING OF THE ACETABULAR COMPONENT. PATIENT PREVIOUSLY HAD A CLOSED REDUCTION PROCEDURE ON (B)(6) 2019. INTRAOPERATIVELY, THERE WAS A HEMOLYZED HEMATOMA WHICH WAS IRRIGATED AND WASHED FREE. THE ENTIRE POSTERIOR CAPSULE AND SHORT EXTERNAL ROTATORS HAD BEEN DAMAGED FROM THE DISLOCATION. THE ACETABULAR COMPONENT WAS NOTED TO HAD FLATTENED OUT AND WAS ALMOST RETROVERTED AND FLAT IN THE NEUTRAL POSITION. DOI: (B)(6) 2010; DOR: (B)(6) 2010; (LEFT HIP).

  Patient problems: Hematoma; Joint Dislocation

  MAUDE report 9203735 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED VIA THA (DATE OF SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP (MANUFACTURED BY KYOCERA, P/N: 121782050) TO A MOBILE CUP (MANUFACTURED BY OTHER COMPANIES), THE INSERT (P/N: 121889150), THE HEAD (P/N: 136511500) TO A DELTA TS HEAD DUE TO LOOSENING AROUND THE CUP CAUSED BY OSTEOLYSIS WHICH POSSIBLE CAUSE WAS NECK JUNCTION. THE SURGERY WAS COMPLETED WITHOUT PROBLEM, AND IT WAS UNKNOWN THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8962643 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SUBJECTED TO A SURGICAL PROCEDURE AT HER LEFT FEMUR ON DATE (B)(6) 2003 IN WHICH RECEIVED AN IMPLANT WITH CORAIL STEM, PINNACLE CUP AND METAL INSERT. THE PATIENT IN THE FOLLOWING PERIOD STARTED TO ACCUSE PAIN AND ONSET OF METAL IONS CR-CO AND OTHER METALLIC IONS. THESE PROBLEMS GOT WORSE : THE METALLIC VALUES INCREASE TILL TO A TUMEFACTION OF THE HIP DUE TO METALLOSIS. THE PATIENT WAS SUBJECTED TO A REVISION. DOI: (B)(6) 2003 - DOR: NONE REPORTED (UNK HIP).

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Scar Tissue; Swelling; Test Result

  MAUDE report 8808804 ↗
• InjuryApr 18, 2019Naturally Worn; Naturally Worn

  AFTER REVIEW MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, ANTERIOR INSTABILITY AND METALLOSIS. OPERATIVE FINDINGS REPORTED METALLOSIS, BACKSIDE WEAR OF THE METAL LINER IN THE ACETABULAR SHELL AND SIGNIFICANT RETROVERSION OF ACETABULAR SHELL. LEFT HIP.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8527463 ↗
• InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION AND DAMAGED THE CONSTRAINED LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8416146 ↗