PINNACLE 1217-12-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295009153), received between Oct 26, 2017 and Apr 5, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PAIN AND INFECTION. SURGEON DECIDED TO COMPLETE REVISION IN TWO STAGES. CORAIL STEM AND PINNACLE CUP WERE REMOVED; ZIMMER BIOMET CPT STEM AND A DEPUY CEMENTED CUP WAS UTILISED AS A TEMPORARY SPACER - TO BE REMOVED AT A LATER STAGE. JOINT WAS WASHED OUT AND TEMPORARY SPACER WAS INSERTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14017220 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY REQUIRED DUE TO LUXATION OF THE POLY. CUP WAS REVISED BECAUSE THE HEAD HAD BEEN SCRATCHING AGAINST THE CUP. NO SURGICAL DELAY. DATE OF PRIMARY IMPLANTATION: (B)(6) 2019 DATE OF REVISION: (B)(6) 2021 OPERATIVE SIDE: RIGHT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12121028 ↗
• InjurySep 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON SAID THAT HE HAD BOOKED A PATIENT FOR REVISION OF A DISSOCIATED PINNACLE LINER FOR SURGERY TODAY (B)(6). REVISION ON DISSOCIATED LINER WAS COMPLETED AS PLANNED AND SURGEON IMPLANTED A 32MM ID/50MM OD ALTRX POLY NEUTRAL LINER AND 32MM +9 BIOLOX DELTA TS CERAMIC FEMORAL HEAD (REVISION). EXPLANTED HEAD AND LINER NOT AVAILABLE FOR RETURN. PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2018. SURGEON DID NOT SUGGEST WHY THE LINER HAD FAILED/DISSOCIATED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10607370 ↗
• InjuryAug 26, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED MECHANICAL FAILURE LEFT INTERNAL PROSTHESIS, FAILED METAL ON METAL HIP REPLACEMENT. OPERATIVES NOTES ELEVATED COBALT AND CHROMIUM LEVEL, EXTENSIVE METALLOSIS, MINIMAL BONE LOSS AND MINIMAL TRUNNIONOSIS ON THE FEMORAL NECK. THERE WAS DAMAGE TO THE ACETABULAR LOCKING MECHANISM AND DECISION WAS MADE TO REMOVE THE CUP. DOI: (B)(6) 2009. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Distress; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 10454887 ↗
• InjuryJan 28, 2020Corroded; Difficult to Remove; Corroded; Difficult to Remove

  IT WAS REPORTED THAT THE DR. TEXTED THE SALES REP AND SAID "I HAVE A METAL ON METAL REVISION HIP COMING UP I WANTED TO SEE WHAT MY HEADLINER OPTIONS WERE". AFTER A BRIEF PHONE CALL, THE SURGEON DECIDED THAT HE WAS GOING TO TRY TO PRESERVE THE CUP, REMOVE THE METAL LINER AND PREOPERATIVE PLAN WAS TO TRIAL AND REPLACE LINER WITH +4/10° AND +9 32MM HEAD. DR. COULD NOT REMOVE METAL LINER USING A AB EXTRACTOR, RECIPROCATING SAW, AND BONE TAMPS. DR DECIDED TO REMOVE ENTIRE CUT IMPLANT ZIMMER ACETABULAR CUP AND LINER AND ALSO IMPLANT +5 TS 32 MM HEAD. NOTHING WAS SAID ABOUT THE METAL ON METAL LINER BUT THERE WAS AN OBVIOUS UNDERSTANDING THAT IT WAS AN ISSUE BASED ON THE EXPLANT AND TISSUE SURROUNDING THE CUP. THERE WAS A SURGICAL DELAY OF 1 HOUR AND 30 MINS. DOI: (B)(6) 2008; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Tissue Damage; Weakness

  MAUDE report 9636448 ↗
• InjuryApr 1, 2019Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem

  PATIENT UNDERWENT SPINAL SURGERY AFTER HER HIP WAS REPLACED AND THEN REPORTED ONGOING GROIN PAIN SHE DISLOCATED REQUIRING REVISION SURGERY. DURING REVISION SURGERY BLACK SUBSTANCE WAS NOTED AROUND THE CORAIL STEM TRUNNION AND THE CERAMIC HEAD WAS BLACK. LINER DISASSOCIATED FROM THE CUP.

  Patient problems: Pain

  MAUDE report 8468889 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. AS STATED " RECEIVED A METAL ON METAL HIP REPLACEMENT 2006. WENT FOR 12 YEARS TO MULTIPLE DOCTORS WHO REFUSED TO TAKE CARE OF ME. SEVERE WORSENING PAIN FROM THE DAY IT WAS PLACED UNTIL 2018. IN THIS TIME I EXPERIENCED PAIN, NEUROPATHY, RASHES, ITCHING, ANXIETY, DEPRESSION, COGNITIVE ISSUES. MADE FUN FOR YEARS BECAUSE OF THE NOISES THE HIP MADE WITH EVERY STEP. ALL DOCTORS EVER DID WERE X-RAYS AND THEY ALWAYS STATED THE HIP WAS IN PLACE. THE FDA ALLOWED THIS DEVICE INTO THE MARKET AND I HAVE BEEN SEVERELY INJURED AND HAVE LIFELONG DISABILITIES BECAUSE OF THE METAL ON METAL HIP. NOW, COMPLETELY UNABLE TO RETURN TO MY CAREER AS A REGISTERED NURSE, METAL LEVELS OVER 49, SEPSIS, PSEUDOTUMORS, NECROSIS AND BONE LOSS. ANTIBIOTIC SPACER PLACED 2018 FOR OVER 8 MONTHS AND REVISION ON 2018. ALL COMPLETED AT MEDICAL CENTER".

  Patient problems: Anxiety; Bone Fracture(s); Depression; Discomfort; Injury; Itching Sensation; Necrosis; Neuropathy; No Code Available; Osteolysis; Pain; Rash; Tissue Damage; Unspecified Infection

  MAUDE report 8444294 ↗
• InjuryFeb 18, 2019Difficult to Remove; Difficult to Remove

  THE SURGEON DECIDED THAT HE WAS GOING TO TRY TO PRESERVE THE CUP, REMOVE THE METAL LINER AND PREOPERATIVE PLAN WAS TO TRIAL AND REPLACE LINER WITH +4/10° AND +9 32MM HEAD. DR. COULD NOT REMOVE METAL LINER USING A AB EXTRACTOR, RECIPROCATING SAW, AND BONE TAMPS. DR. DECIDED TO REMOVE ENTIRE CUP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8347995 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, METALLOSIS, METAL POISONING, LACK OF MOBILITY, INJURY AND DISABILITY, EMOTIONAL DISTRESS, ANXIETY, DEPRESSION, AND A FEELING LOOSENESS IN HER LEFT HIP. DOI: (B)(6) 2008; DOR: NOT REVISED; LEFT HIP.

  Patient problems: Anxiety; Depression; Distress; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain

  MAUDE report 7510392 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LETTER FROM EXPRESS SOLICITORS REF (B)(4). ON (B)(6) 2009- TOTAL RIGHT HIP REPLACEMENT. (B)(6) 2010 - PATIENT COMPLAINED TO GP OF INCREASED PAIN IN RIGHT LEG ANF HIP. X-RAY AND BLOOD TESTS WERE NORMAL. ON (B)(6) 2011 - ASPIRATION OF RIGHT HIP. ASPIRATE WAS NORMAL. PATIENT CONTINUED TO EXPERIENCE PAIN AND DISCOMFORT. ALSO SUFFERED REDNESS AND SWELLING IN RIGHT LOWER LIMB. (B)(6) 2011 - BLOOD TESTS CONFIRMED RAISED COBALT AND CHROMIUM. (B)(6) 2011 - GP NOTED SYMPTOMS WERE DISABLING AND PATIENT WAS KEEN FOR REVISION. (B)(6) 2011 - REVISION. NOW MAKING STEADY PROGRESS BUT STILL SUFFERS FROM PAIN. SOLICITOR REQUESTING THE FOLLOWING DOCUMENTS BE MADE AVAILABLE FOR EACH OF THE PRODUCTS PINNACLE, APEX, CORAIL, ARTICULEZE; PRODUCT SPECIFICATIONS, DESIGN DOCUMENTS, SAFETY AND SAFETY TESTING OF THE PRODUCTS. DOCUMENTS RELATING TO INVESTIGATIONS OF REPORTS OF INCREASED BLOOD IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Discomfort; Pain; Swelling; Tissue Damage

  MAUDE report 7241061 ↗
• InjuryOct 26, 2017Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS POLYETHYLENE WEAR. THE SURGEON FELT THE CUP ORIENTATION NEEDED REVISING.

  Patient problems: No Information

  MAUDE report 6982405 ↗