PINNACLE 1219-36-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295014607), received between Aug 18, 2017 and Dec 11, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S DISLOCATION ORIGINAL WAS DONE 10 PLUS YEARS AGO. A POLY SWAP REVISION WAS DONE 2 YEARS AGO. THE PATIENT EXPERIENCED WEAR THROUGH THE ACETABULAR CUP AND LINER, NECESSITATING A REVISION PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23783169 ↗
• 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 22833174 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP DISLOCATED. DOI: (B)(6) 2005. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22366384 ↗
• InjuryJan 9, 2023Naturally Worn; Naturally Worn

  REVISION OF CORAIL PINNACLE THR DUE TO PERI-PROSTHETIC FRACTURE. VANCOUVER B2 TYPE FRACTURE. STEM WAS REMOVED AND ZIMMER DISTAL FIXING STEM INSERTED. DUE TO AGE OF LINER IT WAS ALSO CHANGED FOR NEW ALTRX ONE. HEAD AND LINER SHOWED MINIMAL WEAR AND NIL FURTHER ISSUES. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information

  MAUDE report 16120529 ↗
• InjuryMay 12, 2022Adverse 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 AND PAIN 10 YEARS POST PRIMARY THA IN (B)(6). DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14381759 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2018 WHERE A CORAIL PINNACLE WAS UTILIZED. PATIENT WAS BROUGHT BACK TO THEATRE ON (B)(6) 2020 WHERE IT SEEMS THERE WAS AN ATTEMPT TO REMOVE THE STEM FOR ONGOING PAIN AND POSSIBLE INFECTION. DUE TO THE DIFFICULTY OF REMOVING THE STEM, THE STEM WAS LEFT IN SITU AND THE HEAD EXCHANGED (I DO NOT HAVE ANY ADDITIONAL DETAILS, PLEASE CHECK TO SEE WHETHER THERE WAS A PRODUCT COMPLAINT SUBMITTED AT THIS TIME) PATIENT HAS NOW PRESENTED ON THE GOLD COAST WITH ONGOING PAIN. A DECISION WAS MADE TO OPEN THE HIP AND REMOVE THE STEM (AS IT APPEARS ON X RAY THAT THE STEM MAY BE LOOSE). ON OPENING THE HIP A FROZEN SECTION WAS TAKEN AND SHOWS THE HIP TO BE INFECTED. ALL IMPLANTS WERE REMOVED AND A CEMENTED STEM LOOSELY CEMENTED IN SITU AND PINNACLE LINER ALSO LOOSELY CEMENTED IN - BOTH TO ACT AS A TEMPORARY SPACER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12562416 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRIMARY HIP REPLACEMENT ON THE (B)(6) 2020 - RETURNED TO THEATRE TODAY FOR A WASH OUT AND HEAD AND LINER EXCHANGE FOR SUSPECTED INFECTION.

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

  MAUDE report 11130997 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF HAS NO ALLEGATIONS. DOI: (B)(6) 2006. DOR: (B)(6) 2008; (RIGHT HIP).

  Patient problems: Extraskeletal ossification; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9885832 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8554877 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES ELEVATED METAL IONS, ABDUCTOR MUSCLE REPIAR, OPEN DISLOCATION AND LOOSENING OF CUP AND STEM. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INSTABILITY FROM TOTAL HIP ARTHROSCOPY. REVISION NOTES REPORTED THAT THE STEM WAS WELL FIXED AND INSTABILITY WAS FIXED. DOI: (B)(6) 2014 - DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 8477860 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, SORENESS, DIFFICULTY WALKING, DECREASED MOBILITY AND/OR THE NEED FOR REVISION SURGERY SINCE IMPLANTATION OF THE DEVICES. UPDATE AD 17 JAN 2019: RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF HAD NO ALLEGATION. ADDED LAW FIRM, PATIENT IDENTIFIER, AGE, PRODUCT DETAILS AND IMPACTED PRODUCTS (CUP, LINER, HEAD, STEM) SINCE LEGACY REPORTED ONLY ONE UNKNOWN DEPUY PINNACLE HIP. DOI: (B)(6) 2006; DOR: NOT REPORTED; (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 8300903 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8257029 ↗
• InjuryDec 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS BEEN CONTINUING TO DISLOCATE. THE SURGEON ELECTED TO EXPLANT THE SHELL, LINER AND HEAD FROM A MOP CONSTRUCT TO A CUP CONSTRAINED CONSTRUCT.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8169521 ↗
• InjuryDec 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS IMMEDIATE POST-OP DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8141687 ↗
• InjuryOct 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES LOOSENING OF CUP AND DISLOCATION WITH CLOSED REDUCTION. PATIENT WAS REVISED TO ADDRESS STATUS POST TOTAL HIP ARTHROPLASTY.

  Patient problems: Joint Dislocation; Not Applicable; Scarring

  MAUDE report 7927544 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PINNACLE PPF AND IMPLANT STICKER RECEIVED WERE PART AND LOT IDENTIFIED. PPF HAS NO ALLEGATION(S) REPORTED. DOI: (B)(6) 2006; DOR: NOT REPORTED; LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641569 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THE SURGEON STATED PATIENT HAD THREE PREVIOUS SURGERIES BUT HAD NOT DISLOCATED WITH THIS LAST REVISION. SHE WAS COMPLAINING OF PAIN AND INSISTED SURGERY. THE SURGEON FOUND THE CUP TO BE WELL FIXED BUT DECIDED TO REMOVE. HE THEN USED ANOTHER MANUFACTURED REV. CUP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7472725 ↗
• InjuryApr 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP REVISION, (B)(6), (B)(6), (B)(6) 2018. PRIMARY IMPLANT DATE (B)(6) 2018. SEVERAL EPISODES OF DISLOCATION OF RIGHT HIP ON DISCHARGE FROM HOSPITAL. PATIENT REQUIRED CUP REVISION. SURGEON FELT INTRA-OPERATIVELY STEM NEEDED UP-SIZING. MALE PATIENT ID: (B)(6), AGED (B)(6), DOB: (B)(6).

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7453848 ↗
• InjuryFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION FOR DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7299007 ↗
• InjuryFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. THEY PUT A 40 LINER AND MADE A TRIPOLAR WITH 40 BIPOLAR AND 28 TS +12 HEAD. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7298943 ↗
• InjuryNov 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATIONS X3 WITHIN A 2 WEEK PERIOD. LINER AND HEAD REMOVED AND SCAR TISSUE FROM THE ANTERIOR PORTION OF THE HIP. ALSO, A CONSTRAINED LINER WAS IMPLANTED AND A PLUA 5 FEMORAL HEAD. HIP WAS STABLE ON THE TABLE. BOTH STEM AND CUP WERE WELL FIXED AND LEFT IN SITUE.

  Patient problems: Joint Dislocation; No Consequences Or Impact To Patient; Scar Tissue

  MAUDE report 7002203 ↗
• InjuryOct 10, 2017Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS ANTERIOR DISLOCATION AND PATIENT REPORTED FEELING SHORT LEG.

  Patient problems: No Code Available

  MAUDE report 6934064 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 6805251 ↗